Breast Cancer
Conditions
Brief summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Interventions
DRUGPaclitaxel
Paclitaxel will be administered as per the schedule specified in the respective arm.
DRUGPertuzumab
Pertuzumab will be administered as per the schedule specified in the respective arm.
DRUGPlacebo
Placebo will be administered as per the schedule specified in the respective arm.
DRUGTrastuzumab
Trastuzumab will be administered as per the schedule specified in the respective arm.
DRUGDocetaxel
Docetaxel will be administered as per the schedule specified in the respective arm.
DRUGDoxorubicin
Doxorubicin will be administered as per the schedule specified in the respective arm.
DRUGEpirubicin
Epirubicin will be administered as per the schedule specified in the respective arm.
DRUG5-Fluorouracil
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
DRUGCarboplatin
Carboplatin will be administered as per the schedule specified in the respective arm.
DRUGCyclophosphamide
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Sponsors
Genentech, Inc.
Breast International Group
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1 * Known hormone receptor status (estrogen receptor and progesterone receptor) * The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first * Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan * Confirmed HER2 positive status * Completion of all necessary baseline laboratory and radiologic investigations prior to randomization * Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug
Exclusion criteria
* History of any prior (ipsi- and/or contralateral) invasive breast cancer * History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin * Any clinical T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer * Any node-negative tumor * Any previous systemic chemotherapy for cancer or radiotherapy for cancer * Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer * Concurrent anti-cancer treatment in another investigational trial * Serious cardiac or cardiovascular disease or condition * Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness * Abnormal laboratory tests immediately prior to randomization * Pregnant or lactating women * Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is \[i.e.\], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ \[DCIS\] and lobular carcinoma in situ \[LCIS\]) and non-melanoma skin cancer were excluded as an event. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at 3 years is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free. |
| Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | Kaplan-Meier estimates of the percentage of participants who were DFS event-free at 6, 8, and 10 years are reported. DFS was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, SPNBC, or contralateral or ipsilateral DCIS. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free. |
| Percentage of Participants Who Died, First Interim Overall Survival Analysis | Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants who died due to any cause is reported. |
| Percentage of Participants Who Died, Final Overall Survival Analysis | Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years) | Percentage of participants who died due to any cause is reported. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years | 3 years | The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 6, 8, and 10 years | The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive. |
| Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were RFI event-free at 3 years is reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | Kaplan-Meier estimates of the percentage of participants who were RFI event-free at 6, 8, and 10 years are reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death. |
| Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at 3 years is reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death. |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | Kaplan-Meier estimates of the percentage of participants who were DRFI event-free at 6, 8, and 10 years are reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death. |
| Percentage of Participants With Primary Cardiac Event, Primary Analysis | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) | Primary cardiac event was defined as either: Heart Failure (New York Heart Association \[NYHA\] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. |
| Percentage of Participants With Primary Cardiac Event, Final Analysis | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) | Primary cardiac event was defined as either: Heart Failure (New York Heart Association \[NYHA\] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. |
| Percentage of Participants With Secondary Cardiac Event, Primary Analysis | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) | Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB). |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free. |
| Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) | LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan. |
| Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) | LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan. |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36 | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. |
| Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement. |
| Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms. |
| Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties. |
| Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. |
| Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. |
| Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding. |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding. |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding. |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding. |
| Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36 | EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding. |
| Trough Serum Concentration (Cmin) of Pertuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) | — |
| Cmin of Trastuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) | — |
| Peak Serum Concentration (Cmax) of Pertuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) | — |
| Cmax of Trastuzumab | Cycles 1, 10 and 15 (Cycle length=21 days) | — |
| Percentage of Participants With Secondary Cardiac Event, Final Analysis | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) | Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB). |
| Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, El Salvador, France, Germany, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Romania, Russia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Overall, 4804 patients were randomized in the study, 2400 in the Pertuzumab arm and 2404 in the Placebo arm.
Pre-assignment details
A total of 6263 patients were screened for the study. The most common cause of screen failure was lack of confirmation of HER2-positivity by the central laboratory which accounted for approximately half of the screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg). | 2,400 |
| Placebo + Trastuzumab + Chemotherapy Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg). | 2,404 |
| Total | 4,804 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 39 | 42 |
| Overall Study | Contralateral breast cancer | 42 | 28 |
| Overall Study | Death | 41 | 46 |
| Overall Study | Lost to Follow-up | 181 | 176 |
| Overall Study | Physician Decision | 43 | 32 |
| Overall Study | Reason not specified | 37 | 29 |
| Overall Study | Recurrence of disease | 181 | 269 |
| Overall Study | Withdrawal by Subject | 475 | 466 |
Baseline characteristics
| Characteristic | Pertuzumab + Trastuzumab + Chemotherapy | Total | Placebo + Trastuzumab + Chemotherapy |
|---|---|---|---|
| Adjuvant Chemotherapy Regimen Anthracycline containing regimen | 1865 Participants | 3742 Participants | 1877 Participants |
| Adjuvant Chemotherapy Regimen Non-anthracycline containing regimen | 535 Participants | 1062 Participants | 527 Participants |
| Age, Continuous | 51.7 years STANDARD_DEVIATION 10.9 | 51.5 years STANDARD_DEVIATION 10.8 | 51.4 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 87 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 432 Participants | 818 Participants | 386 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1923 Participants | 3899 Participants | 1976 Participants |
| Hormone Receptor Status Negative (ER and PgR negative) | 864 Participants | 1722 Participants | 858 Participants |
| Hormone Receptor Status Positive (ER and/or PgR positive) | 1536 Participants | 3082 Participants | 1546 Participants |
| Nodal Status 0 Positive Nodes and Tumor ≤1 cm | 90 Participants | 174 Participants | 84 Participants |
| Nodal Status 0 Positive Nodes and Tumor >1 cm | 807 Participants | 1625 Participants | 818 Participants |
| Nodal Status 1 to 3 Positive Nodes | 907 Participants | 1807 Participants | 900 Participants |
| Nodal Status ≥4 Positive Nodes | 596 Participants | 1198 Participants | 602 Participants |
| Protocol Version at Enrollment Protocol Version A | 1828 Participants | 3655 Participants | 1827 Participants |
| Protocol Version at Enrollment Protocol Version B | 572 Participants | 1149 Participants | 577 Participants |
| Race/Ethnicity, Customized Asian | 590 Participants | 1188 Participants | 598 Participants |
| Race/Ethnicity, Customized Black | 32 Participants | 73 Participants | 41 Participants |
| Race/Ethnicity, Customized Not reported | 7 Participants | 9 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 66 Participants | 135 Participants | 69 Participants |
| Race/Ethnicity, Customized White | 1705 Participants | 3399 Participants | 1694 Participants |
| Sex: Female, Male Female | 2397 Participants | 4793 Participants | 2396 Participants |
| Sex: Female, Male Male | 3 Participants | 11 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 205 / 2,400 | 247 / 2,404 |
| other Total, other adverse events | 2,353 / 2,364 | 2,374 / 2,405 |
| serious Total, serious adverse events | 792 / 2,364 | 686 / 2,405 |
Outcome results
Primary
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at 3 years is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.
Time frame: 3 years
Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (excluding SPNBC) at 3 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 94.06 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 93.24 Estimate of percentage of participants |
Primary
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is \[i.e.\], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ \[DCIS\] and lobular carcinoma in situ \[LCIS\]) and non-melanoma skin cancer were excluded as an event.
Time frame: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 7.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8.7 percentage of participants |
Comparison: Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.p-value: 0.044695% CI: [0.66, 1]Log Rank
Secondary
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Hair Loss | 10.9 units on a scale | Standard Deviation 40.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Arm Symptoms | -4.0 units on a scale | Standard Deviation 21.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Arm Symptoms | -5.1 units on a scale | Standard Deviation 21.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Arm Symptoms | -5.9 units on a scale | Standard Deviation 21.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline: Breast Symptoms | 19.5 units on a scale | Standard Deviation 17.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Breast Symptoms | -5.0 units on a scale | Standard Deviation 18.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Breast Symptoms | 1.9 units on a scale | Standard Deviation 20.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Breast Symptoms | -0.6 units on a scale | Standard Deviation 20.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Breast Symptoms | -3.0 units on a scale | Standard Deviation 18.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Breast Symptoms | -6.4 units on a scale | Standard Deviation 18.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Breast Symptoms | -7.3 units on a scale | Standard Deviation 18.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Hair Loss | 8.3 units on a scale | Standard Deviation 38 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline:Systemic SE | 9.5 units on a scale | Standard Deviation 10.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Systemic SE | 21.1 units on a scale | Standard Deviation 17.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Systemic SE | 9.2 units on a scale | Standard Deviation 14.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Systemic SE | 8.3 units on a scale | Standard Deviation 15.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Systemic SE | 4.4 units on a scale | Standard Deviation 12.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Systemic SE | 4.1 units on a scale | Standard Deviation 13.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Systemic SE | 4.5 units on a scale | Standard Deviation 13.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline: Hair Loss | 26.4 units on a scale | Standard Deviation 32.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Hair Loss | 17.3 units on a scale | Standard Deviation 43.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Hair Loss | -7.0 units on a scale | Standard Deviation 36 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Hair Loss | -4.1 units on a scale | Standard Deviation 39.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Hair Loss | -5.6 units on a scale | Standard Deviation 42.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline: Arm Symptoms | 21.6 units on a scale | Standard Deviation 19.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Arm Symptoms | -4.7 units on a scale | Standard Deviation 20.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Arm Symptoms | -2.9 units on a scale | Standard Deviation 21.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Arm Symptoms | -3.5 units on a scale | Standard Deviation 21.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Arm Symptoms | -2.1 units on a scale | Standard Deviation 21.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Systemic SE | 7.5 units on a scale | Standard Deviation 14.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Arm Symptoms | -3.9 units on a scale | Standard Deviation 22.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Hair Loss | 3.2 units on a scale | Standard Deviation 34.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Arm Symptoms | -5.0 units on a scale | Standard Deviation 22.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Systemic SE | 5.5 units on a scale | Standard Deviation 13.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Arm Symptoms | -4.7 units on a scale | Standard Deviation 22.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline: Arm Symptoms | 21.7 units on a scale | Standard Deviation 19.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline: Breast Symptoms | 20.4 units on a scale | Standard Deviation 17.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Systemic SE | 4.9 units on a scale | Standard Deviation 13.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Breast Symptoms | -5.2 units on a scale | Standard Deviation 18 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Hair Loss | 0.7 units on a scale | Standard Deviation 36 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Breast Symptoms | -0.4 units on a scale | Standard Deviation 20.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Systemic SE | 5.2 units on a scale | Standard Deviation 13.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Breast Symptoms | -3.8 units on a scale | Standard Deviation 19.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Arm Symptoms | -2.3 units on a scale | Standard Deviation 21.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 18: Breast Symptoms | -5.9 units on a scale | Standard Deviation 18.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline: Hair Loss | 22.1 units on a scale | Standard Deviation 29 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 24: Breast Symptoms | -7.3 units on a scale | Standard Deviation 18.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Hair Loss | 2.4 units on a scale | Standard Deviation 34.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at FU Month 36: Breast Symptoms | -7.9 units on a scale | Standard Deviation 19 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Hair Loss | 21.2 units on a scale | Standard Deviation 37.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Hair Loss | 14.5 units on a scale | Standard Deviation 38.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Baseline:Systemic SE | 10.2 units on a scale | Standard Deviation 11.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Arm Symptoms | -3.4 units on a scale | Standard Deviation 21.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 13: Systemic SE | 21.7 units on a scale | Standard Deviation 17.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at EOT: Hair Loss | 17.9 units on a scale | Standard Deviation 39.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score | Change at Week 25: Systemic SE | 8.2 units on a scale | Standard Deviation 14.2 |
Secondary
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Dyspnea | 6.8 units on a scale | Standard Deviation 15.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Diarrhea | 22.3 units on a scale | Standard Deviation 29.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Diarrhea | 13.2 units on a scale | Standard Deviation 26.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Diarrhea | 12.2 units on a scale | Standard Deviation 26.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Diarrhea | -0.5 units on a scale | Standard Deviation 17.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Diarrhea | -0.8 units on a scale | Standard Deviation 17.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Diarrhea | -0.8 units on a scale | Standard Deviation 16.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Fatigue | 22.4 units on a scale | Standard Deviation 19.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Fatigue | 16.1 units on a scale | Standard Deviation 24.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Fatigue | 7.8 units on a scale | Standard Deviation 22.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Fatigue | 7.1 units on a scale | Standard Deviation 23 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Fatigue | 1.1 units on a scale | Standard Deviation 21.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Fatigue | 0.4 units on a scale | Standard Deviation 22 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Fatigue | -0.2 units on a scale | Standard Deviation 21.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Diarrhea | 5.2 units on a scale | Standard Deviation 14.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Dyspnea | 12.3 units on a scale | Standard Deviation 23.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Dyspnea | 6.3 units on a scale | Standard Deviation 19.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Dyspnea | 6.6 units on a scale | Standard Deviation 20.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Dyspnea | 5.9 units on a scale | Standard Deviation 21 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Dyspnea | 5.1 units on a scale | Standard Deviation 20.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Dyspnea | 5.1 units on a scale | Standard Deviation 20.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Appetite Loss | 8.5 units on a scale | Standard Deviation 18.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Appetite Loss | 13.6 units on a scale | Standard Deviation 29.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Appetite Loss | 5.2 units on a scale | Standard Deviation 25.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Appetite Loss | 3.0 units on a scale | Standard Deviation 24.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Appetite Loss | -3.0 units on a scale | Standard Deviation 20.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Appetite Loss | -3.2 units on a scale | Standard Deviation 20.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Appetite Loss | -3.0 units on a scale | Standard Deviation 20.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Insomnia | 25.3 units on a scale | Standard Deviation 27.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Insomnia | 6.3 units on a scale | Standard Deviation 30.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Insomnia | 4.3 units on a scale | Standard Deviation 30.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Insomnia | 3.2 units on a scale | Standard Deviation 31 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Insomnia | -0.1 units on a scale | Standard Deviation 31.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Insomnia | -1.5 units on a scale | Standard Deviation 31.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Insomnia | -0.3 units on a scale | Standard Deviation 31.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: N/V | 2.7 units on a scale | Standard Deviation 8.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: N/V | 5.6 units on a scale | Standard Deviation 15.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: N/V | 1.1 units on a scale | Standard Deviation 11.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: N/V | 1.6 units on a scale | Standard Deviation 12.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: N/V | -0.2 units on a scale | Standard Deviation 10.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: N/V | 0.0 units on a scale | Standard Deviation 10.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: N/V | 0.3 units on a scale | Standard Deviation 11 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Constipation | 8.7 units on a scale | Standard Deviation 19.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Constipation | 1.4 units on a scale | Standard Deviation 23.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Constipation | -0.7 units on a scale | Standard Deviation 21.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Constipation | 0.1 units on a scale | Standard Deviation 22.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Constipation | 3.0 units on a scale | Standard Deviation 23.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Constipation | 2.1 units on a scale | Standard Deviation 23.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Constipation | 2.1 units on a scale | Standard Deviation 22.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Pain | 18.8 units on a scale | Standard Deviation 21.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Pain | 2.3 units on a scale | Standard Deviation 25.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Pain | 1.4 units on a scale | Standard Deviation 24.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Pain | 0.1 units on a scale | Standard Deviation 24.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Pain | -1.3 units on a scale | Standard Deviation 23.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Pain | -1.6 units on a scale | Standard Deviation 24.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Pain | -2.6 units on a scale | Standard Deviation 24.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Pain | 0.5 units on a scale | Standard Deviation 25.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Diarrhea | 5.1 units on a scale | Standard Deviation 13.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Insomnia | 27.3 units on a scale | Standard Deviation 28.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Diarrhea | 9.2 units on a scale | Standard Deviation 23.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Constipation | 10.0 units on a scale | Standard Deviation 19.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Diarrhea | 3.3 units on a scale | Standard Deviation 19.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Insomnia | 5.1 units on a scale | Standard Deviation 32.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Diarrhea | 2.9 units on a scale | Standard Deviation 20 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Pain | 19.6 units on a scale | Standard Deviation 22.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Diarrhea | 0.2 units on a scale | Standard Deviation 17.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Insomnia | 2.0 units on a scale | Standard Deviation 31.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Diarrhea | 0.2 units on a scale | Standard Deviation 18.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Constipation | 4.1 units on a scale | Standard Deviation 25.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Diarrhea | 0.3 units on a scale | Standard Deviation 16.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Insomnia | 0.9 units on a scale | Standard Deviation 32.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Fatigue | 23.2 units on a scale | Standard Deviation 20.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Pain | -2.2 units on a scale | Standard Deviation 25.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Fatigue | 16.2 units on a scale | Standard Deviation 24.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Insomnia | 0.4 units on a scale | Standard Deviation 32.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Fatigue | 6.6 units on a scale | Standard Deviation 22.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Constipation | 0.2 units on a scale | Standard Deviation 22.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Fatigue | 5.2 units on a scale | Standard Deviation 23 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Insomnia | -1.1 units on a scale | Standard Deviation 32.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Fatigue | 1.2 units on a scale | Standard Deviation 22.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Pain | 5.0 units on a scale | Standard Deviation 26.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Fatigue | 0.4 units on a scale | Standard Deviation 22.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Insomnia | -0.5 units on a scale | Standard Deviation 33.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Fatigue | 0.6 units on a scale | Standard Deviation 22.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Constipation | 0.9 units on a scale | Standard Deviation 23.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Dyspnea | 8.0 units on a scale | Standard Deviation 17.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: N/V | 3.1 units on a scale | Standard Deviation 9.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Dyspnea | 14.6 units on a scale | Standard Deviation 26.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Pain | -0.5 units on a scale | Standard Deviation 25.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Dyspnea | 6.4 units on a scale | Standard Deviation 22.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: N/V | 3.7 units on a scale | Standard Deviation 14.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Dyspnea | 6.5 units on a scale | Standard Deviation 22.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Constipation | 1.5 units on a scale | Standard Deviation 23.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Dyspnea | 5.0 units on a scale | Standard Deviation 21.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: N/V | 0.5 units on a scale | Standard Deviation 12.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Dyspnea | 5.3 units on a scale | Standard Deviation 22.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Pain | 1.4 units on a scale | Standard Deviation 24.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Dyspnea | 5.3 units on a scale | Standard Deviation 22.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: N/V | 0.8 units on a scale | Standard Deviation 13.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Baseline: Appetite Loss | 9.1 units on a scale | Standard Deviation 18.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Constipation | 0.6 units on a scale | Standard Deviation 22.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 13: Appetite Loss | 7.7 units on a scale | Standard Deviation 27.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: N/V | -0.4 units on a scale | Standard Deviation 12.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at Week 25: Appetite Loss | 0.3 units on a scale | Standard Deviation 22.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Pain | -2.3 units on a scale | Standard Deviation 25 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at EOT: Appetite Loss | -0.9 units on a scale | Standard Deviation 22.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: N/V | -0.1 units on a scale | Standard Deviation 11.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 18: Appetite Loss | -3.1 units on a scale | Standard Deviation 21.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Constipation | 1.5 units on a scale | Standard Deviation 22.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 24: Appetite Loss | -3.3 units on a scale | Standard Deviation 21 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: N/V | 0.2 units on a scale | Standard Deviation 11.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores | Change at FU Month 36: Appetite Loss | -2.7 units on a scale | Standard Deviation 21.2 |
Secondary
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at Week 25 | 2.3 units on a scale | Standard Deviation 26.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at FU Month 18 | -4.1 units on a scale | Standard Deviation 27.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at Week 13 | 3.1 units on a scale | Standard Deviation 26.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at FU Month 24 | -5.2 units on a scale | Standard Deviation 28.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at EOT | -0.2 units on a scale | Standard Deviation 27.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at FU Month 36 | -7.1 units on a scale | Standard Deviation 28.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Baseline | 20.3 units on a scale | Standard Deviation 28.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at FU Month 36 | -8.3 units on a scale | Standard Deviation 28.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Baseline | 22.1 units on a scale | Standard Deviation 30 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at Week 13 | 1.7 units on a scale | Standard Deviation 27 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at Week 25 | -0.3 units on a scale | Standard Deviation 26.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at EOT | -1.5 units on a scale | Standard Deviation 27.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at FU Month 18 | -5.1 units on a scale | Standard Deviation 27.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores | Change at FU Month 24 | -6.9 units on a scale | Standard Deviation 29.3 |
Secondary
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Physical | 89.6 units on a scale | Standard Deviation 12.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Social | 5.0 units on a scale | Standard Deviation 23.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Role | -0.7 units on a scale | Standard Deviation 26.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Social | 5.5 units on a scale | Standard Deviation 24.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Physical | -0.9 units on a scale | Standard Deviation 13.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Social | 6.6 units on a scale | Standard Deviation 24.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Role | 0.4 units on a scale | Standard Deviation 27.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Cognitive | 88.8 units on a scale | Standard Deviation 16.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Physical | -4.6 units on a scale | Standard Deviation 14.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Cognitive | -9.1 units on a scale | Standard Deviation 20.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Role | 6.1 units on a scale | Standard Deviation 26.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Cognitive | -7.6 units on a scale | Standard Deviation 20.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Physical | -0.4 units on a scale | Standard Deviation 13.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Cognitive | -7.7 units on a scale | Standard Deviation 20.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Role | 7.3 units on a scale | Standard Deviation 26.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Cognitive | -6.1 units on a scale | Standard Deviation 19.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Physical | -10.7 units on a scale | Standard Deviation 17.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Cognitive | -6.2 units on a scale | Standard Deviation 20.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Role | 7.9 units on a scale | Standard Deviation 26.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Cognitive | -5.4 units on a scale | Standard Deviation 20.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Physical | -0.3 units on a scale | Standard Deviation 14.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Emotional | 72.8 units on a scale | Standard Deviation 22.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Social | 81.9 units on a scale | Standard Deviation 22.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Emotional | 3.3 units on a scale | Standard Deviation 22.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Physical | -4.1 units on a scale | Standard Deviation 14.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Emotional | 5.1 units on a scale | Standard Deviation 22.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Social | -8.7 units on a scale | Standard Deviation 25.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Emotional | 5.6 units on a scale | Standard Deviation 23.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Role | 79.8 units on a scale | Standard Deviation 24.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Emotional | 7.7 units on a scale | Standard Deviation 23.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Social | -2.2 units on a scale | Standard Deviation 24.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Emotional | 7.8 units on a scale | Standard Deviation 23.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Role | -8.0 units on a scale | Standard Deviation 28.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Emotional | 7.8 units on a scale | Standard Deviation 23.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Social | 0.0 units on a scale | Standard Deviation 25.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Emotional | 8.4 units on a scale | Standard Deviation 24.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Physical | 89.1 units on a scale | Standard Deviation 13.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Physical | -10.6 units on a scale | Standard Deviation 17.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Physical | -4.3 units on a scale | Standard Deviation 14.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Physical | -3.2 units on a scale | Standard Deviation 14.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Physical | -0.9 units on a scale | Standard Deviation 14.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Physical | -0.3 units on a scale | Standard Deviation 14.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Physical | -0.1 units on a scale | Standard Deviation 13.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Role | -8.5 units on a scale | Standard Deviation 29.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Role | 0.4 units on a scale | Standard Deviation 27.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Role | 2.3 units on a scale | Standard Deviation 28.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Role | 5.7 units on a scale | Standard Deviation 28.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Role | 6.9 units on a scale | Standard Deviation 28.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Role | 7.6 units on a scale | Standard Deviation 27.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Social | 80.6 units on a scale | Standard Deviation 24.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Social | -7.8 units on a scale | Standard Deviation 27.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Social | -0.7 units on a scale | Standard Deviation 26.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Social | 1.2 units on a scale | Standard Deviation 26.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Social | 4.8 units on a scale | Standard Deviation 26.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Social | 6.5 units on a scale | Standard Deviation 26.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Social | 7.1 units on a scale | Standard Deviation 27.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Cognitive | 87.9 units on a scale | Standard Deviation 17.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Cognitive | -9.0 units on a scale | Standard Deviation 21.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Cognitive | -7.0 units on a scale | Standard Deviation 20.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Cognitive | -7.2 units on a scale | Standard Deviation 21.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Cognitive | -5.8 units on a scale | Standard Deviation 21.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Cognitive | -5.5 units on a scale | Standard Deviation 21.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 36: Cognitive | -4.9 units on a scale | Standard Deviation 21.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Emotional | 71.3 units on a scale | Standard Deviation 22.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 13: Emotional | 2.9 units on a scale | Standard Deviation 22.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at Week 25: Emotional | 5.9 units on a scale | Standard Deviation 22.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at EOT: Emotional | 6.2 units on a scale | Standard Deviation 23.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 18: Emotional | 7.6 units on a scale | Standard Deviation 23.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Change at FU Month 24: Emotional | 8.5 units on a scale | Standard Deviation 24.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores | Baseline: Role | 79.4 units on a scale | Standard Deviation 25.2 |
Secondary
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: Sexual Function | 19.6 units on a scale | Standard Deviation 23.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: Body Image | -0.1 units on a scale | Standard Deviation 23.3 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: Sexual Function | -5.6 units on a scale | Standard Deviation 20.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: Sexual Enjoyment | -16.5 units on a scale | Standard Deviation 28.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: Sexual Function | -2.6 units on a scale | Standard Deviation 20.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: Body Image | -12.9 units on a scale | Standard Deviation 24.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: Sexual Function | -1.0 units on a scale | Standard Deviation 20.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: Sexual Enjoyment | -11.9 units on a scale | Standard Deviation 26.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: Sexual Function | 2.5 units on a scale | Standard Deviation 22.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24: Body Image | 0.5 units on a scale | Standard Deviation 23.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24: Sexual Function | 2.8 units on a scale | Standard Deviation 22.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: Sexual Enjoyment | -10.7 units on a scale | Standard Deviation 27.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: Sexual Function | 2.6 units on a scale | Standard Deviation 24 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: Body Image | -4.9 units on a scale | Standard Deviation 23.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: FP | 51.3 units on a scale | Standard Deviation 31.7 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: Sexual Enjoyment | -4.2 units on a scale | Standard Deviation 28.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: FP | 3.1 units on a scale | Standard Deviation 30.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: Body Image | 1.7 units on a scale | Standard Deviation 24.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: FP | 6.3 units on a scale | Standard Deviation 31.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24: Sexual Enjoyment | -6.0 units on a scale | Standard Deviation 28.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: FP | 7.7 units on a scale | Standard Deviation 32.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: Body Image | -7.6 units on a scale | Standard Deviation 23.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: FP | 12.9 units on a scale | Standard Deviation 32 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: Sexual Enjoyment | -5.3 units on a scale | Standard Deviation 28.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24 : FP | 13.7 units on a scale | Standard Deviation 32.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: Sexual Enjoyment | 54.0 units on a scale | Standard Deviation 30.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: FP | 14.7 units on a scale | Standard Deviation 34.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: Body Image | 79.7 units on a scale | Standard Deviation 23.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: FP | 13.6 units on a scale | Standard Deviation 32.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: Body Image | 78.9 units on a scale | Standard Deviation 23.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: Body Image | -13.9 units on a scale | Standard Deviation 25.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: Body Image | -7.3 units on a scale | Standard Deviation 23.4 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: Body Image | -6.0 units on a scale | Standard Deviation 24.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: Body Image | -1.3 units on a scale | Standard Deviation 23.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24: Body Image | 0.1 units on a scale | Standard Deviation 23.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: Body Image | 0.7 units on a scale | Standard Deviation 24.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: Sexual Enjoyment | 55.0 units on a scale | Standard Deviation 30.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: Sexual Enjoyment | -13.1 units on a scale | Standard Deviation 27.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: Sexual Enjoyment | -7.9 units on a scale | Standard Deviation 26.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: Sexual Enjoyment | -8.0 units on a scale | Standard Deviation 27.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: Sexual Enjoyment | -6.7 units on a scale | Standard Deviation 26.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24: Sexual Enjoyment | -5.0 units on a scale | Standard Deviation 27.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: Sexual Enjoyment | -6.0 units on a scale | Standard Deviation 26.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: Sexual Function | 20.8 units on a scale | Standard Deviation 24.3 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: Sexual Function | -6.6 units on a scale | Standard Deviation 20.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: Sexual Function | -2.3 units on a scale | Standard Deviation 20.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: Sexual Function | -1.4 units on a scale | Standard Deviation 21.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: Sexual Function | 1.4 units on a scale | Standard Deviation 21.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24: Sexual Function | 1.8 units on a scale | Standard Deviation 22.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 36: Sexual Function | 1.6 units on a scale | Standard Deviation 23.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Baseline: FP | 50.5 units on a scale | Standard Deviation 31.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 13: FP | 1.8 units on a scale | Standard Deviation 31.9 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at Week 25: FP | 5.4 units on a scale | Standard Deviation 31.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at EOT: FP | 6.9 units on a scale | Standard Deviation 31.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 18: FP | 10.5 units on a scale | Standard Deviation 32 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score | Change at FU Month 24 : FP | 12.9 units on a scale | Standard Deviation 32.9 |
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
Time frame: Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
Population: ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at Week 25 | -4.4 units on a scale | Standard Deviation 21.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at FU Month 18 | 1.9 units on a scale | Standard Deviation 21.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at Week 13 | -11.2 units on a scale | Standard Deviation 22.8 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at FU Month 24 | 2.2 units on a scale | Standard Deviation 22.1 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at EOT | -3.1 units on a scale | Standard Deviation 21.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at FU Month 36 | 2.8 units on a scale | Standard Deviation 21.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Baseline | 72.9 units on a scale | Standard Deviation 19.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at FU Month 36 | 1.8 units on a scale | Standard Deviation 22.5 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Baseline | 72.5 units on a scale | Standard Deviation 19.7 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at Week 13 | -10.2 units on a scale | Standard Deviation 22.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at Week 25 | -2.9 units on a scale | Standard Deviation 21 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at EOT | -1.1 units on a scale | Standard Deviation 21.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at FU Month 18 | 1.3 units on a scale | Standard Deviation 22.2 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score | Change at FU Month 24 | 2.4 units on a scale | Standard Deviation 22.1 |
Secondary
Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Time frame: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Population: Safety population. The overall number of participants analyzed is the number of participants evaluable for this outcome measure. Number analyzed is the number of participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis | Baseline | 65.2 percentage of blood pumped out | Standard Deviation 5.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis | Change to Worst Value | -8.6 percentage of blood pumped out | Standard Deviation 6.8 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis | Baseline | 65.3 percentage of blood pumped out | Standard Deviation 6.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis | Change to Worst Value | -8.6 percentage of blood pumped out | Standard Deviation 7 |
95% CI: [-0.4, 0.4]
Secondary
Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Time frame: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Population: Safety population. The overall number of participants analyzed is the number of participants evaluable for this outcome measure. Number analyzed is the number of participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis | Baseline | 65.2 percentage of blood pumped out | Standard Deviation 5.9 |
| Pertuzumab + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis | Change to Worst Value | -7.5 percentage of blood pumped out | Standard Deviation 6.6 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis | Baseline | 65.3 percentage of blood pumped out | Standard Deviation 6.1 |
| Placebo + Trastuzumab + Chemotherapy | Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis | Change to Worst Value | -7.6 percentage of blood pumped out | Standard Deviation 6.7 |
95% CI: [-0.3, 0.5]
Secondary
Cmax of Trastuzumab
Time frame: Cycles 1, 10 and 15 (Cycle length=21 days)
Population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Cmax of Trastuzumab | Cycle 1 | 180 mcg/mL | Standard Deviation 81 |
| Pertuzumab + Trastuzumab + Chemotherapy | Cmax of Trastuzumab | Cycle 10 | 219 mcg/mL | Standard Deviation 94.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Cmax of Trastuzumab | Cycle 15 | 187 mcg/mL | Standard Deviation 95.1 |
| Placebo + Trastuzumab + Chemotherapy | Cmax of Trastuzumab | Cycle 1 | 190 mcg/mL | Standard Deviation 51.6 |
| Placebo + Trastuzumab + Chemotherapy | Cmax of Trastuzumab | Cycle 10 | 225 mcg/mL | Standard Deviation 70.7 |
| Placebo + Trastuzumab + Chemotherapy | Cmax of Trastuzumab | Cycle 15 | 234 mcg/mL | Standard Deviation 73.5 |
Secondary
Cmin of Trastuzumab
Time frame: Cycles 1, 10 and 15 (Cycle length=21 days)
Population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Cmin of Trastuzumab | Cycle 1 | 32.1 mcg/mL | Standard Deviation 13.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Cmin of Trastuzumab | Cycle 10 | 65.0 mcg/mL | Standard Deviation 39.6 |
| Pertuzumab + Trastuzumab + Chemotherapy | Cmin of Trastuzumab | Cycle 15 | 72.9 mcg/mL | Standard Deviation 46.1 |
| Placebo + Trastuzumab + Chemotherapy | Cmin of Trastuzumab | Cycle 1 | 34.1 mcg/mL | Standard Deviation 11.4 |
| Placebo + Trastuzumab + Chemotherapy | Cmin of Trastuzumab | Cycle 10 | 68.4 mcg/mL | Standard Deviation 23 |
| Placebo + Trastuzumab + Chemotherapy | Cmin of Trastuzumab | Cycle 15 | 71.0 mcg/mL | Standard Deviation 30.4 |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.
Time frame: 3 years
Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for death at Year 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years | 97.65 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years | 97.67 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.
Time frame: 6, 8, and 10 years
Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for death at at the time of analysis for each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 6 Years | 94.78 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 8 Years | 92.74 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 10 Years | 91.55 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 8 Years | 91.96 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 10 Years | 89.79 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 6 Years | 93.93 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Time frame: 3 years
Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DFS event at 3 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 93.42 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 92.29 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were DFS event-free at 6, 8, and 10 years are reported. DFS was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, SPNBC, or contralateral or ipsilateral DCIS. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
Time frame: 6, 8, and 10 years
Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 88.99 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 86.92 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 85.01 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 86.03 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 83.19 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 80.54 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at 3 years is reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Time frame: 3 years
Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DRFI event at 3 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 95.70 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 95.13 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were DRFI event-free at 6, 8, and 10 years are reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Time frame: 6, 8, and 10 years
Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at at the time of analysis for each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 93.37 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 92.94 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 92.85 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 91.57 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 90.69 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 90.01 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
Time frame: 6, 8, and 10 years
Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 90.56 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 88.43 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 87.17 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 87.76 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 85.76 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 83.82 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Time frame: 3 years
Population: ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (including SPNBC) at 3 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 93.50 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 92.51 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
Time frame: 6, 8, and 10 years
Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 89.31 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 87.08 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 85.23 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 86.42 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 83.82 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 81.31 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were RFI event-free at 3 years is reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Time frame: 3 years
Population: ITT population. Overall number of participants analyzed=participants remaining at risk for RFI event at 3 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 95.18 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 94.27 Estimate of percentage of participants |
Secondary
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were RFI event-free at 6, 8, and 10 years are reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Time frame: 6, 8, and 10 years
Population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at at the time of analysis for each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 92.49 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 92.11 Estimate of percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 91.87 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6 Years | 89.91 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8 Years | 88.88 Estimate of percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 10 Years | 88.10 Estimate of percentage of participants |
Secondary
Peak Serum Concentration (Cmax) of Pertuzumab
Time frame: Cycles 1, 10 and 15 (Cycle length=21 days)
Population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Peak Serum Concentration (Cmax) of Pertuzumab | Cycle 1 | 237 mcg/mL | Standard Deviation 118 |
| Pertuzumab + Trastuzumab + Chemotherapy | Peak Serum Concentration (Cmax) of Pertuzumab | Cycle 10 | 222 mcg/mL | Standard Deviation 92.2 |
| Pertuzumab + Trastuzumab + Chemotherapy | Peak Serum Concentration (Cmax) of Pertuzumab | Cycle 15 | 206 mcg/mL | Standard Deviation 94.9 |
Secondary
Percentage of Participants Who Died, Final Overall Survival Analysis
Percentage of participants who died due to any cause is reported.
Time frame: Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants Who Died, Final Overall Survival Analysis | 8.54 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants Who Died, Final Overall Survival Analysis | 10.27 percentage of participants |
Comparison: Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.p-value: 0.044195% CI: [0.69, 1]Log Rank
Secondary
Percentage of Participants Who Died, First Interim Overall Survival Analysis
Percentage of participants who died due to any cause is reported.
Time frame: Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants Who Died, First Interim Overall Survival Analysis | 3.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants Who Died, First Interim Overall Survival Analysis | 3.7 percentage of participants |
Comparison: Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.p-value: 0.467395% CI: [0.66, 1.21]Log Rank
Secondary
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Time frame: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 8.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 9.8 percentage of participants |
Comparison: Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.p-value: 0.032795% CI: [0.67, 0.98]Log Rank
Secondary
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.
Time frame: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 5.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6.0 percentage of participants |
Comparison: Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.p-value: 0.100795% CI: [0.64, 1.04]Log Rank
Secondary
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Time frame: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 7.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 9.6 percentage of participants |
Comparison: Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.p-value: 0.04395% CI: [0.68, 0.99]Log Rank
Secondary
Percentage of Participants With Primary Cardiac Event, Final Analysis
Primary cardiac event was defined as either: Heart Failure (New York Heart Association \[NYHA\] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.
Time frame: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Population: Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Final Analysis | Primary Cardiac Event (Composite) | 0.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Final Analysis | Heart Failure and LVEF Decline | 0.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Final Analysis | Cardiac Death (Definite or Probable) | 0.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Final Analysis | Primary Cardiac Event (Composite) | 0.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Final Analysis | Heart Failure and LVEF Decline | 0.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Final Analysis | Cardiac Death (Definite or Probable) | 0.2 percentage of participants |
95% CI: [-0.1, 0.9]
Secondary
Percentage of Participants With Primary Cardiac Event, Primary Analysis
Primary cardiac event was defined as either: Heart Failure (New York Heart Association \[NYHA\] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.
Time frame: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Population: Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Primary Analysis | Primary Cardiac Event (Composite) | 0.7 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Primary Analysis | Heart Failure and LVEF Decline | 0.6 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Primary Analysis | Cardiac Death (Definite or Probable) | 0.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Primary Analysis | Primary Cardiac Event (Composite) | 0.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Primary Analysis | Heart Failure and LVEF Decline | 0.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Primary Cardiac Event, Primary Analysis | Cardiac Death (Definite or Probable) | 0.1 percentage of participants |
95% CI: [0, 0.8]
Secondary
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Time frame: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 5.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 7.2 percentage of participants |
Comparison: Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.p-value: 0.04395% CI: [0.63, 0.99]Log Rank
Secondary
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Baseline: Not anxious/depress | 47.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Baseline: Moderate anxious/depress | 49.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Baseline: Extreme anxious/depress | 3.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 13: Not anxious/depress | 53.6 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 13: Moderate anxious/depress | 43.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 13: Extreme anxious/depress | 3.0 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 25: No anxious/depress | 55.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 25: Moderate anxious/depress | 41.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 25: Extreme anxious/depress | 2.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | EOT: Not anxious/depress | 58.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | EOT: Moderate anxious/depress | 38.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | EOT: Extreme anxious/depress | 2.6 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 18: Not anxious/depress | 61.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 18: Moderate anxious/depress | 36.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 18: Extreme anxious/depress | 2.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 24: Not anxious/depress | 63.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 24: Moderate anxious/depress | 33.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 24: Extreme anxious/depress | 2.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 36: Not anxious/depress | 64.0 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 36: Moderate anxious/depress | 33.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 36: Extreme anxious/depress | 2.6 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | EOT: Moderate anxious/depress | 39.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Baseline: Not anxious/depress | 44.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 36: Not anxious/depress | 61.6 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Baseline: Moderate anxious/depress | 50.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | EOT: Extreme anxious/depress | 2.6 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Baseline: Extreme anxious/depress | 5.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 24: Moderate anxious/depress | 36.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 13: Not anxious/depress | 52.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 18: Not anxious/depress | 59.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 13: Moderate anxious/depress | 44.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 36: Extreme anxious/depress | 3.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 13: Extreme anxious/depress | 3.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 18: Moderate anxious/depress | 37.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 25: No anxious/depress | 55.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 24: Extreme anxious/depress | 2.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 25: Moderate anxious/depress | 41.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 18: Extreme anxious/depress | 3.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | Week 25: Extreme anxious/depress | 2.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 36: Moderate anxious/depress | 35.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | EOT: Not anxious/depress | 58.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain | FU Month 24: Not anxious/depress | 61.0 percentage of participants |
Secondary
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Baseline: No pain/discomfort | 49.0 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Baseline: Moderate pain/discomfort | 50.0 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Baseline: Extreme pain/discomfort | 1.0 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 13: No pain/discomfort | 44.6 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 13: Moderate pain/discomfort | 52.7 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 13: Extreme pain/discomfort | 2.7 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 25: No pain/discomfort | 44.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 25: Moderate pain/discomfort | 53.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 25: Extreme pain/discomfort | 2.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | EOT: No pain/discomfort | 49.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | EOT: Moderate pain/discomfort | 48.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | EOT: Extreme pain/discomfort | 2.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 18: No pain/discomfort | 51.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 18: Moderate pain/discomfort | 46.6 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 18: Extreme pain/discomfort | 2.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 24: No pain/discomfort | 56.7 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 24: Moderate pain/discomfort | 41.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 24: Extreme pain/discomfort | 1.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 36: No pain/discomfort | 59.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 36: Moderate pain/discomfort | 38.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 36: Extreme pain/discomfort | 1.6 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | EOT: Moderate pain/discomfort | 47.6 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Baseline: No pain/discomfort | 49.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 36: No pain/discomfort | 57.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Baseline: Moderate pain/discomfort | 49.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | EOT: Extreme pain/discomfort | 2.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Baseline: Extreme pain/discomfort | 1.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 24: Moderate pain/discomfort | 41.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 13: No pain/discomfort | 40.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 18: No pain/discomfort | 53.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 13: Moderate pain/discomfort | 56.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 36: Extreme pain/discomfort | 2.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 13: Extreme pain/discomfort | 3.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 18: Moderate pain/discomfort | 44.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 25: No pain/discomfort | 43.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 24: Extreme pain/discomfort | 2.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 25: Moderate pain/discomfort | 54.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 18: Extreme pain/discomfort | 2.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | Week 25: Extreme pain/discomfort | 1.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 36: Moderate pain/discomfort | 40.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | EOT: No pain/discomfort | 50.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain | FU Month 24: No pain/discomfort | 56.0 percentage of participants |
Secondary
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 36: Unable | 0.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Baseline: Some problems | 10.0 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Baseline: Unable | 0.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 13: No problems | 94.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 13: Some problems | 5.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 13: Unable | 0.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 25: No problems | 95.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 25: Some problems | 4.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 25: Unable | 0.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | EOT: No problems | 95.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | EOT: Some problems | 4.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | EOT: Unable | 0.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 18: No problems | 97.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 18: Some problems | 2.6 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 18: Unable | 0.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 24: No problems | 96.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 24: Some problems | 2.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 24: Unable | 0.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 36: No problems | 97.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 36: Some problems | 2.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Baseline: No problems | 89.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | EOT: Some problems | 4.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Baseline: No problems | 90.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 36: No problems | 96.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Baseline: Some problems | 9.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | EOT: Unable | 0.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Baseline: Unable | 0.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 24: Some problems | 3.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 13: No problems | 93.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 18: No problems | 96.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 13: Some problems | 6.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 36: Unable | 0.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 13: Unable | 0.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 18: Some problems | 3.6 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 25: No problems | 95.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 24: Unable | 0.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 25: Some problems | 4.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 18: Unable | 0.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | Week 25: Unable | 0.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 36: Some problems | 3.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | EOT: No problems | 95.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain | FU Month 24: No problems | 96.3 percentage of participants |
Secondary
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 13: Unable | 3.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Baseline: No problems | 67.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 25: No problems | 66.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 24: Unable | 0.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 25: Some problems | 32.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Baseline: Some problems | 30.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 25: Unable | 1.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 36: Some problems | 18.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | EOT: No problems | 72.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Baseline: Unable | 2.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | EOT: Some problems | 26.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 24: Some problems | 20.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | EOT: Unable | 1.3 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 13: No problems | 56.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 18: No problems | 78.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 36: Unable | 0.7 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 18: Some problems | 20.6 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 13: Some problems | 40.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 18: Unable | 0.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 36: No problems | 80.9 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 24: No problems | 78.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 25: Some problems | 32.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 24: Some problems | 19.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 24: Unable | 1.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 36: No problems | 79.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 36: Some problems | 19.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 36: Unable | 0.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Baseline: No problems | 66.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Baseline: Some problems | 32.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Baseline: Unable | 1.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 13: No problems | 54.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 13: Some problems | 43.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 13: Unable | 2.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 25: No problems | 65.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 24: No problems | 79.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | Week 25: Unable | 1.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | EOT: No problems | 72.5 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | EOT: Some problems | 26.6 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | EOT: Unable | 0.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 18: No problems | 76.3 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 18: Some problems | 23.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain | FU Month 18: Unable | 0.7 percentage of participants |
Secondary
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.
Time frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Population: ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Baseline: No problems | 93.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Baseline: Some problems | 6.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Baseline: Confined to bed | 0.0 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 13: No problems | 77.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 13: Some problems | 22.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 13: Confined to bed | 0.4 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 25: No problems | 83.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 25: Some problems | 16.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 25: Confined to bed | 0.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | EOT: No problems | 85.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | EOT: Some problems | 14.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | EOT: Confined to bed | 0.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 18: No problems | 88.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 18: Some problems | 11.2 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 18: Confined to bed | 0.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 24: No problems | 87.8 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 24: Some problems | 12.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 24: Confined to bed | 0.1 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 36: No problems | 88.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 36: Some problems | 11.5 percentage of participants |
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 36: Confined to bed | 0.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | EOT: Some problems | 14.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Baseline: No problems | 92.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 36: No problems | 87.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Baseline: Some problems | 6.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | EOT: Confined to bed | 0.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Baseline: Confined to bed | 0.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 24: Some problems | 12.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 13: No problems | 74.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 18: No problems | 87.0 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 13: Some problems | 24.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 36: Confined to bed | 0.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 13: Confined to bed | 0.4 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 18: Some problems | 12.8 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 25: No problems | 82.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 24: Confined to bed | 0.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 25: Some problems | 17.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 18: Confined to bed | 0.2 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | Week 25: Confined to bed | 0.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 36: Some problems | 12.1 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | EOT: No problems | 84.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain | FU Month 24: No problems | 87.7 percentage of participants |
Secondary
Percentage of Participants With Secondary Cardiac Event, Final Analysis
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).
Time frame: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Secondary Cardiac Event, Final Analysis | 2.9 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Secondary Cardiac Event, Final Analysis | 3.0 percentage of participants |
95% CI: [-1.1, 0.9]
Secondary
Percentage of Participants With Secondary Cardiac Event, Primary Analysis
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).
Time frame: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Percentage of Participants With Secondary Cardiac Event, Primary Analysis | 2.7 percentage of participants |
| Placebo + Trastuzumab + Chemotherapy | Percentage of Participants With Secondary Cardiac Event, Primary Analysis | 2.8 percentage of participants |
95% CI: [-1, 0.9]
Secondary
Trough Serum Concentration (Cmin) of Pertuzumab
Time frame: Cycles 1, 10 and 15 (Cycle length=21 days)
Population: Pharmacokinetic (PK) evaluable participants were defined as those who received at least one active pertuzumab and/or trastuzumab treatment and had at least one PK sample collected. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Trough Serum Concentration (Cmin) of Pertuzumab | Cycle 10 | 88.1 micrograms per milliliter (mcg/mL) | Standard Deviation 34.4 |
| Pertuzumab + Trastuzumab + Chemotherapy | Trough Serum Concentration (Cmin) of Pertuzumab | Cycle 15 | 95.5 micrograms per milliliter (mcg/mL) | Standard Deviation 51.5 |
| Pertuzumab + Trastuzumab + Chemotherapy | Trough Serum Concentration (Cmin) of Pertuzumab | Cycle 1 | 68.0 micrograms per milliliter (mcg/mL) | Standard Deviation 16.6 |