Breast Cancer
Conditions
Brief summary
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
Interventions
Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days).
Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days).
Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days).
IV infusion of paclitaxel 80 mg/m\^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter \[mg/m\^2\] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m\^2 in the first cycle and escalate to 100 mg/m\^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
Sponsors
Study design
Eligibility
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1 * Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable * HER2-positive breast cancer * Known hormone receptor status of the primary tumor * Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy * Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer \[UICC/AJCC\] 7th edition): eligible participants must have either: Node-positive disease (pN more than or equal to \[\>/=\] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size \>2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory * Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive * No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization * Baseline left ventricular ejection fraction (LVEF) \>/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans * Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required * Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment
Exclusion criteria
* History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma * History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin * Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer * For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable) * Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy * History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study * Participants with contraindication to RT while adjuvant RT is clinically indicated * Concurrent anti-cancer treatment in another investigational trial * Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade \>/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy * Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV * Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines * Inadequate hematologic, renal or liver function * Pregnant or lactating women * Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol * Chronic immunosuppressive therapies, including systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above. | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization. |
| Invasive Disease-Free Survival (IDFS) in the Overall Population | First participant randomized up to approximately 7.5 years | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Recurrence-Free Interval (DRFI) | Baseline up to approximately 70 months | DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence. |
| Overall Survival (OS) | First participant randomized up to approximately 7.5 years | OS was defined as the time from randomization to death due to any cause. |
| Percentage of Participants With Adverse Events | From randomization to approximately 7.5 years | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). |
| IDFS Plus Second Primary Non-Breast Cancer | Baseline up to approximately 70 months | IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). |
| EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are 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. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement. |
| Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above. | The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning. |
| Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | First participant randomized up to approximately 7.5 years. | LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans. |
| Disease-Free Survival (DFS) | Baseline up to approximately 70 months | DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS). |
Countries
Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Czechia, El Salvador, France, Georgia, Germany, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Norway, Panama, Peru, Philippines, Poland, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 288 centers in 36 countries.
Pre-assignment details
Randomization was stratified according to geographic region, nodal status, centrally assessed hormonal receptor status and type of anthracycline.
Participants by arm
| Arm | Count |
|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane Trastuzumab and pertuzumab were administered concurrently for up to a total duration of 1 year (up to 18 cycles \[1 Cycle = 21 days\]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline \[5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)\] based chemotherapy. | 918 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab Trastuzumab emtansine and pertuzumab continued for up to a total duration of 1 year (up to 18 cycles \[1 Cycle = 21 days\]) following anthracycline \[5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)\] based chemotherapy. | 928 |
| Total | 1,846 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 44 | 56 |
| Overall Study | Lost to Follow-up | 46 | 39 |
| Overall Study | Physician Decision | 7 | 5 |
| Overall Study | Study Terminated By Sponsor | 758 | 773 |
| Overall Study | Various reasons | 4 | 4 |
| Overall Study | Withdrawal by Subject | 59 | 51 |
Baseline characteristics
| Characteristic | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Total | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane |
|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 10.8 | 51.7 years STANDARD_DEVIATION 10.8 | 51.6 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 68 Participants | 138 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 790 Participants | 1588 Participants | 798 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 70 Participants | 120 Participants | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) Asian | 275 Participants | 542 Participants | 267 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 23 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 65 Participants | 128 Participants | 63 Participants |
| Race (NIH/OMB) White | 565 Participants | 1123 Participants | 558 Participants |
| Sex: Female, Male Female | 926 Participants | 1839 Participants | 913 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 45 / 926 | 55 / 912 |
| other Total, other adverse events | 902 / 926 | 902 / 912 |
| serious Total, serious adverse events | 216 / 926 | 195 / 912 |
Outcome results
Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization.
Time frame: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.
Population: The ITT lymph node positive population was a subpopulation of the randomized participant population including patients with positive lymph node.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | 94.10 Percent Probability |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | 92.75 Percent Probability |
Invasive Disease-Free Survival (IDFS) in the Overall Population
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time frame: First participant randomized up to approximately 7.5 years
Population: The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Invasive Disease-Free Survival (IDFS) in the Overall Population | 94.22 Percent Probability |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Invasive Disease-Free Survival (IDFS) in the Overall Population | 93.06 Percent Probability |
Disease-Free Survival (DFS)
DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS).
Time frame: Baseline up to approximately 70 months
Population: The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Disease-Free Survival (DFS) | 93.32 Percent Probability |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Disease-Free Survival (DFS) | 92.04 Percent Probability |
Distant Recurrence-Free Interval (DRFI)
DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence.
Time frame: Baseline up to approximately 70 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Distant Recurrence-Free Interval (DRFI) | 95.23 Percent Probability |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Distant Recurrence-Free Interval (DRFI) | 94.91 Percent Probability |
EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are 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. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement.
Time frame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
Population: The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Breast Symptoms | -4.2 Units on a Scale | Standard Deviation 18.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Arm Symptoms | 19.9 Units on a Scale | Standard Deviation 18.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Breast Symptoms | -1.0 Units on a Scale | Standard Deviation 19.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Systemic Therapy SE | 24.1 Units on a Scale | Standard Deviation 18.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Systemic Therapy SE | 9.5 Units on a Scale | Standard Deviation 13.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Body Image | -13.7 Units on a Scale | Standard Deviation 23.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Body Image | -11.4 Units on a Scale | Standard Deviation 24.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: FP | 8.2 Units on a Scale | Standard Deviation 32.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Systemic Therapy Side Effects (SE) | 8.5 Units on a Scale | Standard Deviation 9.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Systemic Therapy SE | 24.9 Units on a Scale | Standard Deviation 17.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Systemic Therapy SE | 23.4 Units on a Scale | Standard Deviation 17.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Systemic Therapy SE | 23.1 Units on a Scale | Standard Deviation 18.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Systemic Therapy SE | 20.0 Units on a Scale | Standard Deviation 17.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Systemic Therapy SE | 7.5 Units on a Scale | Standard Deviation 12.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Systemic Therapy SE | 7.2 Units on a Scale | Standard Deviation 13.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Systemic Therapy SE | 5.8 Units on a Scale | Standard Deviation 12.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Systemic Therapy SE | 5.4 Units on a Scale | Standard Deviation 12.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Upset by Hair Loss Item | 13.2 Units on a Scale | Standard Deviation 23.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Upset by Hair Loss Item | 35.1 Units on a Scale | Standard Deviation 37.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Upset by Hair Loss Item | 28.7 Units on a Scale | Standard Deviation 36 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Upset by Hair Loss Item | 28.8 Units on a Scale | Standard Deviation 36.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Upset by Hair Loss Item | 28.4 Units on a Scale | Standard Deviation 37.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Upset by Hair Loss Item | 26.4 Units on a Scale | Standard Deviation 36.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Upset by Hair Loss Item | 11.8 Units on a Scale | Standard Deviation 33.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Upset by Hair Loss Item | 9.3 Units on a Scale | Standard Deviation 32.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Upset by Hair Loss Item | 17.3 Units on a Scale | Standard Deviation 33.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Upset by Hair Loss Item | 6.2 Units on a Scale | Standard Deviation 26.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Upset by Hair Loss Item | 2.4 Units on a Scale | Standard Deviation 28.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Body Image | 78.5 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Body Image | -12.7 Units on a Scale | Standard Deviation 23.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Body Image | -11.5 Units on a Scale | Standard Deviation 24.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Body Image | -10.5 Units on a Scale | Standard Deviation 24.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Body Image | -5.9 Units on a Scale | Standard Deviation 22.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Body Image | -4.5 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Body Image | -3.3 Units on a Scale | Standard Deviation 23.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Body Image | -1.3 Units on a Scale | Standard Deviation 23.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Body Image | 0.0 Units on a Scale | Standard Deviation 24.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Future Perspectives (FP) | 49.3 Units on a Scale | Standard Deviation 31.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: FP | -1.3 Units on a Scale | Standard Deviation 30.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: FP | 1.4 Units on a Scale | Standard Deviation 31.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: FP | 3.2 Units on a Scale | Standard Deviation 32 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: FP | 4.2 Units on a Scale | Standard Deviation 31.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: FP | 5.9 Units on a Scale | Standard Deviation 32.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: FP | 9.5 Units on a Scale | Standard Deviation 32 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: FP | 8.5 Units on a Scale | Standard Deviation 32.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: FP | 10.5 Units on a Scale | Standard Deviation 31.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: FP | 15.0 Units on a Scale | Standard Deviation 34 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Sexual Enjoyment | 43.4 Units on a Scale | Standard Deviation 32.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Sexual Enjoyment | -5.9 Units on a Scale | Standard Deviation 26.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Sexual Enjoyment | -9.5 Units on a Scale | Standard Deviation 30.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Sexual Enjoyment | -11.4 Units on a Scale | Standard Deviation 26.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Sexual Enjoyment | -11.9 Units on a Scale | Standard Deviation 30.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Sexual Enjoyment | -14.2 Units on a Scale | Standard Deviation 28.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Sexual Enjoyment | -9.4 Units on a Scale | Standard Deviation 29.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Sexual Enjoyment | -3.9 Units on a Scale | Standard Deviation 28.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Sexual Enjoyment | -6.5 Units on a Scale | Standard Deviation 29.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Sexual Enjoyment | -4.6 Units on a Scale | Standard Deviation 28.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Sexual Enjoyment | -5.7 Units on a Scale | Standard Deviation 30.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Sexual Function | 16.7 Units on a Scale | Standard Deviation 22.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Sexual Function | -2.3 Units on a Scale | Standard Deviation 18.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Sexual Function | -4.8 Units on a Scale | Standard Deviation 19.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Sexual Function | -5.6 Units on a Scale | Standard Deviation 19.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Sexual Function | -6.8 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Sexual Function | -5.9 Units on a Scale | Standard Deviation 19.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Sexual Function | -3.4 Units on a Scale | Standard Deviation 19.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Sexual Function | -1.8 Units on a Scale | Standard Deviation 20 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Sexual Function | -1.5 Units on a Scale | Standard Deviation 20.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Sexual Function | 1.6 Units on a Scale | Standard Deviation 22.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Sexual Function | 0.9 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Arm Symptoms | -1.3 Units on a Scale | Standard Deviation 19.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Arm Symptoms | -2.8 Units on a Scale | Standard Deviation 18.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Arm Symptoms | -2.0 Units on a Scale | Standard Deviation 19.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Arm Symptoms | -0.5 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Arm Symptoms | -0.2 Units on a Scale | Standard Deviation 20.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Arm Symptoms | 0.3 Units on a Scale | Standard Deviation 21.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Arm Symptoms | 0.1 Units on a Scale | Standard Deviation 21.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Arm Symptoms | -0.1 Units on a Scale | Standard Deviation 22.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Arm Symptoms | -0.8 Units on a Scale | Standard Deviation 22.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Breast Symptoms | 17.5 Units on a Scale | Standard Deviation 17.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Breast Symptoms | -2.3 Units on a Scale | Standard Deviation 16.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Breast Symptoms | -3.3 Units on a Scale | Standard Deviation 17.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Breast Symptoms | -4.0 Units on a Scale | Standard Deviation 17.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Breast Symptoms | -3.9 Units on a Scale | Standard Deviation 17.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Breast Symptoms | -3.1 Units on a Scale | Standard Deviation 18.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Breast Symptoms | 1.7 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Breast Symptoms | -0.2 Units on a Scale | Standard Deviation 18.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Breast Symptoms | -2.5 Units on a Scale | Standard Deviation 19.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Arm Symptoms | -3.5 Units on a Scale | Standard Deviation 18.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Sexual Function | -1.8 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: FP | 7.9 Units on a Scale | Standard Deviation 33.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Arm Symptoms | -3.5 Units on a Scale | Standard Deviation 18.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Arm Symptoms | -1.1 Units on a Scale | Standard Deviation 19.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Arm Symptoms | 0.4 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Breast Symptoms | -2.9 Units on a Scale | Standard Deviation 16.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Breast Symptoms | -1.5 Units on a Scale | Standard Deviation 18.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Breast Symptoms | -3.7 Units on a Scale | Standard Deviation 18 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: FP | 7.6 Units on a Scale | Standard Deviation 32.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Systemic Therapy SE | 11.8 Units on a Scale | Standard Deviation 14.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Sexual Function | -2.8 Units on a Scale | Standard Deviation 20.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: FP | 12.6 Units on a Scale | Standard Deviation 32.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Arm Symptoms | -1.3 Units on a Scale | Standard Deviation 20 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: FP | 13.1 Units on a Scale | Standard Deviation 33.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Sexual Function | -1.7 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Systemic Therapy Side Effects (SE) | 8.7 Units on a Scale | Standard Deviation 9.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Sexual Enjoyment | 46.7 Units on a Scale | Standard Deviation 34.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Systemic Therapy SE | 23.3 Units on a Scale | Standard Deviation 17.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Systemic Therapy SE | 18.3 Units on a Scale | Standard Deviation 16.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Breast Symptoms | -3.3 Units on a Scale | Standard Deviation 17.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Systemic Therapy SE | 15.1 Units on a Scale | Standard Deviation 15.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Sexual Enjoyment | -8.2 Units on a Scale | Standard Deviation 27 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Systemic Therapy SE | 13.2 Units on a Scale | Standard Deviation 15.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Sexual Function | 0.6 Units on a Scale | Standard Deviation 20.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Systemic Therapy SE | 10.4 Units on a Scale | Standard Deviation 14 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Sexual Enjoyment | -10.7 Units on a Scale | Standard Deviation 29.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Systemic Therapy SE | 9.8 Units on a Scale | Standard Deviation 13.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Arm Symptoms | -2.8 Units on a Scale | Standard Deviation 20.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Systemic Therapy SE | 8.5 Units on a Scale | Standard Deviation 13.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Sexual Enjoyment | -8.9 Units on a Scale | Standard Deviation 31.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Systemic Therapy SE | 4.2 Units on a Scale | Standard Deviation 12.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Sexual Function | 0.9 Units on a Scale | Standard Deviation 20.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Systemic Therapy SE | 4.2 Units on a Scale | Standard Deviation 13 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Sexual Enjoyment | -9.2 Units on a Scale | Standard Deviation 28.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Upset by Hair Loss Item | 14.2 Units on a Scale | Standard Deviation 22.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Arm Symptoms | 19.5 Units on a Scale | Standard Deviation 18.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Upset by Hair Loss Item | 25.2 Units on a Scale | Standard Deviation 35.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Sexual Enjoyment | -8.8 Units on a Scale | Standard Deviation 30.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Upset by Hair Loss Item | 21.8 Units on a Scale | Standard Deviation 36.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Breast Symptoms | 0.5 Units on a Scale | Standard Deviation 19.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Upset by Hair Loss Item | 21.4 Units on a Scale | Standard Deviation 38.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Sexual Enjoyment | -7.4 Units on a Scale | Standard Deviation 30.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Upset by Hair Loss Item | 19.7 Units on a Scale | Standard Deviation 34.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Arm Symptoms | -3.1 Units on a Scale | Standard Deviation 18.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Upset by Hair Loss Item | 10.0 Units on a Scale | Standard Deviation 36.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Sexual Enjoyment | -9.7 Units on a Scale | Standard Deviation 31.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Upset by Hair Loss Item | 6.0 Units on a Scale | Standard Deviation 36.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Breast Symptoms | 16.8 Units on a Scale | Standard Deviation 16.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Upset by Hair Loss Item | 2.5 Units on a Scale | Standard Deviation 26 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Sexual Enjoyment | -9.7 Units on a Scale | Standard Deviation 29.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Upset by Hair Loss Item | 0.0 Units on a Scale | Standard Deviation 28.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Arm Symptoms | -3.0 Units on a Scale | Standard Deviation 18.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Upset by Hair Loss Item | -3.5 Units on a Scale | Standard Deviation 21 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Sexual Enjoyment | -3.0 Units on a Scale | Standard Deviation 30.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Upset by Hair Loss Item | -2.8 Units on a Scale | Standard Deviation 29.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Breast Symptoms | -2.6 Units on a Scale | Standard Deviation 18.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Body Image | 78.9 Units on a Scale | Standard Deviation 24.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Body Image | -13.3 Units on a Scale | Standard Deviation 23.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Sexual Enjoyment | -2.3 Units on a Scale | Standard Deviation 31 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Body Image | -10.1 Units on a Scale | Standard Deviation 23.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Arm Symptoms | -2.9 Units on a Scale | Standard Deviation 19.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Body Image | -6.6 Units on a Scale | Standard Deviation 22.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Body Image | -5.9 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Sexual Function | 18.3 Units on a Scale | Standard Deviation 22.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Body Image | -5.0 Units on a Scale | Standard Deviation 22.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Breast Symptoms | -2.5 Units on a Scale | Standard Deviation 16.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Body Image | -4.2 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: Sexual Function | -3.5 Units on a Scale | Standard Deviation 18.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Body Image | -2.4 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Arm Symptoms | -2.6 Units on a Scale | Standard Deviation 19.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Body Image | -2.9 Units on a Scale | Standard Deviation 22.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: Sexual Function | -4.4 Units on a Scale | Standard Deviation 18.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 6: Body Image | 0.3 Units on a Scale | Standard Deviation 23.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at EoT: Breast Symptoms | 0.3 Units on a Scale | Standard Deviation 18.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at FU Month 12: Body Image | 0.7 Units on a Scale | Standard Deviation 23.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Sexual Function | -3.3 Units on a Scale | Standard Deviation 19 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline: Future Perspectives (FP) | 49.8 Units on a Scale | Standard Deviation 30.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: Breast Symptoms | 0.3 Units on a Scale | Standard Deviation 17.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 1: FP | -0.3 Units on a Scale | Standard Deviation 31.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: Sexual Function | -3.4 Units on a Scale | Standard Deviation 17.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 2: FP | 3.7 Units on a Scale | Standard Deviation 30.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 14: Arm Symptoms | 1.3 Units on a Scale | Standard Deviation 21.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: FP | 6.5 Units on a Scale | Standard Deviation 30.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: Sexual Function | -3.0 Units on a Scale | Standard Deviation 19.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 4: FP | 7.8 Units on a Scale | Standard Deviation 30.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 3: Breast Symptoms | -3.1 Units on a Scale | Standard Deviation 16.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 5: FP | 9.7 Units on a Scale | Standard Deviation 30.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Change at Cycle 9: FP | 8.4 Units on a Scale | Standard Deviation 31.3 |
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Time frame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
Population: The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Appetite Loss | 12.0 Units on a Scale | Standard Deviation 28.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Diarrhea | 5.2 Units on a Scale | Standard Deviation 13.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Fatigue | 15.3 Units on a Scale | Standard Deviation 23.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Appetite Loss | 5.7 Units on a Scale | Standard Deviation 23.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Fatigue | 16.0 Units on a Scale | Standard Deviation 23.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Fatigue | 14.9 Units on a Scale | Standard Deviation 22.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Nausea/Vomiting | 4.0 Units on a Scale | Standard Deviation 15.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Fatigue | 8.4 Units on a Scale | Standard Deviation 22 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Appetite Loss | 2.2 Units on a Scale | Standard Deviation 23.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Fatigue | 6.7 Units on a Scale | Standard Deviation 22 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Nausea/Vomiting | 1.1 Units on a Scale | Standard Deviation 12.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Fatigue | 5.5 Units on a Scale | Standard Deviation 22.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Appetite Loss | 0.5 Units on a Scale | Standard Deviation 22.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Fatigue | 1.9 Units on a Scale | Standard Deviation 22.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Dyspnea | 10.4 Units on a Scale | Standard Deviation 21.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Dyspnea | 7.8 Units on a Scale | Standard Deviation 19.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Financial Difficulties | 20.1 Units on a Scale | Standard Deviation 28.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Constipation | 9.6 Units on a Scale | Standard Deviation 19.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Financial Difficulties | 2.2 Units on a Scale | Standard Deviation 25.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Nausea/Vomiting | 0.5 Units on a Scale | Standard Deviation 12.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Constipation | 8.4 Units on a Scale | Standard Deviation 22.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Financial Difficulties | 3.4 Units on a Scale | Standard Deviation 25.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Constipation | 2.5 Units on a Scale | Standard Deviation 24.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Financial Difficulties | 0.9 Units on a Scale | Standard Deviation 25.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Constipation | 1.1 Units on a Scale | Standard Deviation 25 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Financial Difficulties | -1.4 Units on a Scale | Standard Deviation 25.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Constipation | 0.5 Units on a Scale | Standard Deviation 22.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Financial Difficulties | -1.1 Units on a Scale | Standard Deviation 27.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Financial Difficulties | -3.8 Units on a Scale | Standard Deviation 27.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Pain | 5.0 Units on a Scale | Standard Deviation 24.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Financial Difficulties | -5.1 Units on a Scale | Standard Deviation 28.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Constipation | -0.7 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Insomnia | 23.9 Units on a Scale | Standard Deviation 26.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Dyspnea | 6.8 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Insomnia | 3.6 Units on a Scale | Standard Deviation 30.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Constipation | 0.6 Units on a Scale | Standard Deviation 21.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Insomnia | 6.0 Units on a Scale | Standard Deviation 30.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Insomnia | 6.2 Units on a Scale | Standard Deviation 30.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Pain | 3.4 Units on a Scale | Standard Deviation 22.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Insomnia | 5.2 Units on a Scale | Standard Deviation 31.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Insomnia | 4.3 Units on a Scale | Standard Deviation 30.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Insomnia | 2.7 Units on a Scale | Standard Deviation 30.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Constipation | 0.2 Units on a Scale | Standard Deviation 21.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Insomnia | 2.5 Units on a Scale | Standard Deviation 30.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Insomnia | 0.9 Units on a Scale | Standard Deviation 29.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Diarrhea | 4.7 Units on a Scale | Standard Deviation 20.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Insomnia | 0.0 Units on a Scale | Standard Deviation 30.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Pain | 0.0 Units on a Scale | Standard Deviation 23.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Dyspnea | 7.6 Units on a Scale | Standard Deviation 21.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Nausea/Vomiting | 2.6 Units on a Scale | Standard Deviation 9.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Diarrhea | 28.4 Units on a Scale | Standard Deviation 30.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Nausea/Vomiting | 10.4 Units on a Scale | Standard Deviation 19.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Emotional Functioning | 76.0 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Nausea/Vomiting | 6.0 Units on a Scale | Standard Deviation 16.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Diarrhea | 26.5 Units on a Scale | Standard Deviation 30 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Nausea/Vomiting | 5.0 Units on a Scale | Standard Deviation 16.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Appetite Loss | -2.2 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Nausea/Vomiting | 4.7 Units on a Scale | Standard Deviation 16 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Diarrhea | -0.3 Units on a Scale | Standard Deviation 16.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Emotional Functioning | -0.9 Units on a Scale | Standard Deviation 21.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Nausea/Vomiting | 1.1 Units on a Scale | Standard Deviation 13.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Diarrhea | -0.3 Units on a Scale | Standard Deviation 17.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Diarrhea | 32.5 Units on a Scale | Standard Deviation 32.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Nausea/Vomiting | 0.9 Units on a Scale | Standard Deviation 13.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Nausea/Vomiting | 0.2 Units on a Scale | Standard Deviation 11.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Physical Functioning | -2.2 Units on a Scale | Standard Deviation 14.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Pain | 17.4 Units on a Scale | Standard Deviation 20.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Dyspnea | 5.8 Units on a Scale | Standard Deviation 14 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Pain | 1.8 Units on a Scale | Standard Deviation 22.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Role Functioning | 83.1 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Dyspnea | 11.6 Units on a Scale | Standard Deviation 22 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Pain | 3.5 Units on a Scale | Standard Deviation 23.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Fatigue | 2.8 Units on a Scale | Standard Deviation 21.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Pain | 5.4 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Pain | 5.2 Units on a Scale | Standard Deviation 23.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Dyspnea | 13.4 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Pain | 2.0 Units on a Scale | Standard Deviation 23.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Financial Difficulties | 2.0 Units on a Scale | Standard Deviation 25.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Pain | 1.9 Units on a Scale | Standard Deviation 23.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Dyspnea | 14.3 Units on a Scale | Standard Deviation 23.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Pain | 0.8 Units on a Scale | Standard Deviation 23 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Role Functioning | -0.2 Units on a Scale | Standard Deviation 26.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Dyspnea | 13.7 Units on a Scale | Standard Deviation 22.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Diarrhea | 23.9 Units on a Scale | Standard Deviation 30.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Cognitive Functioning | 88.6 Units on a Scale | Standard Deviation 16.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Social Functioning | 83.0 Units on a Scale | Standard Deviation 22.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Cognitive Functioning | -9.7 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Dyspnea | 7.0 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Cognitive Functioning | -9.4 Units on a Scale | Standard Deviation 20 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Social Functioning | -8.0 Units on a Scale | Standard Deviation 24.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Cognitive Functioning | -10.1 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Cognitive Functioning | -11.8 Units on a Scale | Standard Deviation 21.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Dyspnea | 6.2 Units on a Scale | Standard Deviation 20.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Cognitive Functioning | -10.8 Units on a Scale | Standard Deviation 21.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Financial Difficulties | 3.9 Units on a Scale | Standard Deviation 24.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Cognitive Functioning | -8.3 Units on a Scale | Standard Deviation 20.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Social Functioning | -10.1 Units on a Scale | Standard Deviation 26.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Cognitive Functioning | -8.1 Units on a Scale | Standard Deviation 20.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Fatigue | 21.5 Units on a Scale | Standard Deviation 18.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Cognitive Functioning | -8.7 Units on a Scale | Standard Deviation 22.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Social Functioning | -10.3 Units on a Scale | Standard Deviation 26.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Cognitive Functioning | -8.0 Units on a Scale | Standard Deviation 20.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Fatigue | 13.2 Units on a Scale | Standard Deviation 21.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Cognitive Functioning | -7.1 Units on a Scale | Standard Deviation 22.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Financial Difficulties | 3.7 Units on a Scale | Standard Deviation 24.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Fatigue | 15.4 Units on a Scale | Standard Deviation 22.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Emotional Functioning | -1.1 Units on a Scale | Standard Deviation 20.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Physical Functioning | -6.0 Units on a Scale | Standard Deviation 14.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Emotional Functioning | -1.0 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Social Functioning | -8.7 Units on a Scale | Standard Deviation 26.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Physical Functioning | -7.8 Units on a Scale | Standard Deviation 15.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Emotional Functioning | -2.5 Units on a Scale | Standard Deviation 22.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Constipation | 3.4 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Emotional Functioning | -1.2 Units on a Scale | Standard Deviation 22.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Physical Functioning | -7.1 Units on a Scale | Standard Deviation 15.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Emotional Functioning | 3.1 Units on a Scale | Standard Deviation 20.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Social Functioning | -0.1 Units on a Scale | Standard Deviation 25.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Emotional Functioning | 4.1 Units on a Scale | Standard Deviation 21 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Physical Functioning | -8.4 Units on a Scale | Standard Deviation 16.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Emotional Functioning | 3.0 Units on a Scale | Standard Deviation 22.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Social Functioning | 0.3 Units on a Scale | Standard Deviation 26.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Emotional Functioning | 4.7 Units on a Scale | Standard Deviation 21.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Physical Functioning | -8.3 Units on a Scale | Standard Deviation 16.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Emotional Functioning | 5.8 Units on a Scale | Standard Deviation 22.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Diarrhea | 12.6 Units on a Scale | Standard Deviation 24.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Physical Functioning | -4.0 Units on a Scale | Standard Deviation 15 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Physical Functioning | 88.4 Units on a Scale | Standard Deviation 13.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Constipation | 2.8 Units on a Scale | Standard Deviation 22.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Role Functioning | 2.2 Units on a Scale | Standard Deviation 24.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Physical Functioning | -2.7 Units on a Scale | Standard Deviation 14.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Role Functioning | 2.6 Units on a Scale | Standard Deviation 25.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Diarrhea | 12.5 Units on a Scale | Standard Deviation 26.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Appetite Loss | 8.2 Units on a Scale | Standard Deviation 17.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Physical Functioning | -0.6 Units on a Scale | Standard Deviation 14.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Social Functioning | -9.5 Units on a Scale | Standard Deviation 25.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Constipation | 2.0 Units on a Scale | Standard Deviation 24.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Physical Functioning | -0.1 Units on a Scale | Standard Deviation 15.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Social Functioning | -1.7 Units on a Scale | Standard Deviation 25.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Appetite Loss | 12.2 Units on a Scale | Standard Deviation 27.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Appetite Loss | 15.2 Units on a Scale | Standard Deviation 27.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Social Functioning | 3.3 Units on a Scale | Standard Deviation 24.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Role Functioning | -5.1 Units on a Scale | Standard Deviation 24.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Social Functioning | 4.6 Units on a Scale | Standard Deviation 25.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Role Functioning | -9.7 Units on a Scale | Standard Deviation 26.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Insomnia | 8.6 Units on a Scale | Standard Deviation 31.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Global Health Status | 74.3 Units on a Scale | Standard Deviation 18.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Role Functioning | -8.9 Units on a Scale | Standard Deviation 26.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Global Health Status | -7.5 Units on a Scale | Standard Deviation 20.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Global Health Status | -12.4 Units on a Scale | Standard Deviation 22.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Appetite Loss | 14.3 Units on a Scale | Standard Deviation 28.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Global Health Status | -11.7 Units on a Scale | Standard Deviation 20.6 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Global Health Status | -12.7 Units on a Scale | Standard Deviation 21.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Global Health Status | -12.1 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Role Functioning | -10.7 Units on a Scale | Standard Deviation 27.5 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Global Health Status | -5.9 Units on a Scale | Standard Deviation 20.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Diarrhea | 10.3 Units on a Scale | Standard Deviation 25.2 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Global Health Status | -3.9 Units on a Scale | Standard Deviation 21.1 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Role Functioning | -9.4 Units on a Scale | Standard Deviation 27.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Global Health Status | -3.5 Units on a Scale | Standard Deviation 21.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Appetite Loss | 16.2 Units on a Scale | Standard Deviation 29.8 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Global Health Status | -0.6 Units on a Scale | Standard Deviation 21.3 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Role Functioning | -3.3 Units on a Scale | Standard Deviation 25.4 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Global Health Status | -0.2 Units on a Scale | Standard Deviation 21.9 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Appetite Loss | -1.3 Units on a Scale | Standard Deviation 20.7 |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Role Functioning | -0.5 Units on a Scale | Standard Deviation 25 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Social Functioning | -2.6 Units on a Scale | Standard Deviation 23.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Social Functioning | -2.4 Units on a Scale | Standard Deviation 24.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Social Functioning | -1.6 Units on a Scale | Standard Deviation 24.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Social Functioning | 4.0 Units on a Scale | Standard Deviation 24.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Social Functioning | 6.4 Units on a Scale | Standard Deviation 22.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Social Functioning | 33.3 Units on a Scale | Standard Deviation 47.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Global Health Status | 73.9 Units on a Scale | Standard Deviation 18.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Global Health Status | -7.1 Units on a Scale | Standard Deviation 20.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Global Health Status | -5.8 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Global Health Status | -6.4 Units on a Scale | Standard Deviation 20.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Global Health Status | -6.3 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Global Health Status | -4.9 Units on a Scale | Standard Deviation 20.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Global Health Status | 0.3 Units on a Scale | Standard Deviation 21.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Global Health Status | 1.2 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Global Health Status | 16.7 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Insomnia | 1.8 Units on a Scale | Standard Deviation 28.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Appetite Loss | -2.4 Units on a Scale | Standard Deviation 20.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Appetite Loss | -2.3 Units on a Scale | Standard Deviation 20.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Constipation | 0.9 Units on a Scale | Standard Deviation 23.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Constipation | 0.2 Units on a Scale | Standard Deviation 22.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Constipation | -0.6 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Constipation | 2.0 Units on a Scale | Standard Deviation 23.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Constipation | 0.0 Units on a Scale | Standard Deviation 0 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Diarrhea | 4.7 Units on a Scale | Standard Deviation 12.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Diarrhea | 4.2 Units on a Scale | Standard Deviation 18.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Diarrhea | 8.8 Units on a Scale | Standard Deviation 22.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Diarrhea | 4.7 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Diarrhea | 5.1 Units on a Scale | Standard Deviation 20.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Diarrhea | 3.0 Units on a Scale | Standard Deviation 19.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Dyspnea | 6.2 Units on a Scale | Standard Deviation 14.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Dyspnea | 7.5 Units on a Scale | Standard Deviation 21.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Dyspnea | 8.1 Units on a Scale | Standard Deviation 21.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Fatigue | 8.2 Units on a Scale | Standard Deviation 20.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Fatigue | 9.3 Units on a Scale | Standard Deviation 21.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Financial Difficulties | -0.6 Units on a Scale | Standard Deviation 25.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Financial Difficulties | -0.2 Units on a Scale | Standard Deviation 25.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Financial Difficulties | -1.7 Units on a Scale | Standard Deviation 25.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Financial Difficulties | 0.0 Units on a Scale | Standard Deviation 0 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Insomnia | 0.4 Units on a Scale | Standard Deviation 30 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Insomnia | -0.1 Units on a Scale | Standard Deviation 30.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Insomnia | 1.1 Units on a Scale | Standard Deviation 29.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Insomnia | 1.1 Units on a Scale | Standard Deviation 29.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Insomnia | 0.9 Units on a Scale | Standard Deviation 30.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Nausea/Vomiting | 1.7 Units on a Scale | Standard Deviation 12 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Nausea/Vomiting | 0.1 Units on a Scale | Standard Deviation 10.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Nausea/Vomiting | 0.6 Units on a Scale | Standard Deviation 10.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Pain | 3.1 Units on a Scale | Standard Deviation 23.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Pain | 3.9 Units on a Scale | Standard Deviation 23.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Cognitive Functioning | -6.4 Units on a Scale | Standard Deviation 19.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Emotional Functioning | 75.7 Units on a Scale | Standard Deviation 20.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Physical Functioning | 89.1 Units on a Scale | Standard Deviation 12.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Role Functioning | 83.4 Units on a Scale | Standard Deviation 21.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Role Functioning | -5.7 Units on a Scale | Standard Deviation 24.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Role Functioning | 3.7 Units on a Scale | Standard Deviation 23.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Social Functioning | -5.3 Units on a Scale | Standard Deviation 22.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Social Functioning | -3.2 Units on a Scale | Standard Deviation 24.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Social Functioning | -3.4 Units on a Scale | Standard Deviation 24.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Global Health Status | -7.2 Units on a Scale | Standard Deviation 20.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Global Health Status | -5.2 Units on a Scale | Standard Deviation 19.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Global Health Status | -5.5 Units on a Scale | Standard Deviation 19.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Appetite Loss | 7.6 Units on a Scale | Standard Deviation 16.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Appetite Loss | 13.1 Units on a Scale | Standard Deviation 26.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Appetite Loss | 10.3 Units on a Scale | Standard Deviation 25.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Appetite Loss | 9.4 Units on a Scale | Standard Deviation 25.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Appetite Loss | 9.0 Units on a Scale | Standard Deviation 26.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Appetite Loss | 8.2 Units on a Scale | Standard Deviation 25.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Appetite Loss | 6.4 Units on a Scale | Standard Deviation 25.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Appetite Loss | 5.6 Units on a Scale | Standard Deviation 25.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Appetite Loss | -16.7 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Constipation | 9.0 Units on a Scale | Standard Deviation 19.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Constipation | 8.0 Units on a Scale | Standard Deviation 26.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Constipation | -0.4 Units on a Scale | Standard Deviation 22.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Constipation | 3.3 Units on a Scale | Standard Deviation 24.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Constipation | 4.2 Units on a Scale | Standard Deviation 24.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Constipation | 4.7 Units on a Scale | Standard Deviation 25.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Constipation | 1.5 Units on a Scale | Standard Deviation 24.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Diarrhea | 16.0 Units on a Scale | Standard Deviation 26.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Diarrhea | 11.3 Units on a Scale | Standard Deviation 23.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Diarrhea | 10.3 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Diarrhea | -1.1 Units on a Scale | Standard Deviation 16.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Diarrhea | 0.0 Units on a Scale | Standard Deviation 17.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Diarrhea | -16.7 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Dyspnea | 9.2 Units on a Scale | Standard Deviation 21.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Dyspnea | 7.4 Units on a Scale | Standard Deviation 20.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Dyspnea | 6.5 Units on a Scale | Standard Deviation 20.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Dyspnea | 5.9 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Dyspnea | 5.6 Units on a Scale | Standard Deviation 19.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Dyspnea | 8.8 Units on a Scale | Standard Deviation 22.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Dyspnea | 5.3 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Dyspnea | 5.8 Units on a Scale | Standard Deviation 20.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Dyspnea | -16.7 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Fatigue | 20.6 Units on a Scale | Standard Deviation 18.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Fatigue | 14.4 Units on a Scale | Standard Deviation 22.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Physical Functioning | -5.9 Units on a Scale | Standard Deviation 13.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Physical Functioning | -4.8 Units on a Scale | Standard Deviation 12.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Physical Functioning | -4.1 Units on a Scale | Standard Deviation 13 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Physical Functioning | -3.5 Units on a Scale | Standard Deviation 13.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Physical Functioning | -3.5 Units on a Scale | Standard Deviation 13.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Physical Functioning | -3.8 Units on a Scale | Standard Deviation 14.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Physical Functioning | -4.2 Units on a Scale | Standard Deviation 14.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Physical Functioning | -4.9 Units on a Scale | Standard Deviation 15 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Physical Functioning | -1.6 Units on a Scale | Standard Deviation 13.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Physical Functioning | -0.8 Units on a Scale | Standard Deviation 13.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Physical Functioning | 13.3 Units on a Scale | Standard Deviation 18.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Role Functioning | -5.5 Units on a Scale | Standard Deviation 24 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Role Functioning | -2.7 Units on a Scale | Standard Deviation 23.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Role Functioning | -3.2 Units on a Scale | Standard Deviation 23.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Role Functioning | -3.5 Units on a Scale | Standard Deviation 23.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Role Functioning | -3.2 Units on a Scale | Standard Deviation 24.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Role Functioning | -4.3 Units on a Scale | Standard Deviation 25.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Fatigue | 11.2 Units on a Scale | Standard Deviation 21.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Fatigue | 8.7 Units on a Scale | Standard Deviation 20.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Fatigue | 8.4 Units on a Scale | Standard Deviation 21.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Fatigue | 9.8 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Fatigue | 10.6 Units on a Scale | Standard Deviation 22.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Fatigue | 3.1 Units on a Scale | Standard Deviation 21.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Fatigue | 1.8 Units on a Scale | Standard Deviation 20.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Fatigue | -5.6 Units on a Scale | Standard Deviation 39.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Financial Difficulties | 19.9 Units on a Scale | Standard Deviation 28.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Financial Difficulties | 0.3 Units on a Scale | Standard Deviation 24.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Financial Difficulties | -0.4 Units on a Scale | Standard Deviation 25 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Financial Difficulties | 0.7 Units on a Scale | Standard Deviation 26.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Financial Difficulties | -0.5 Units on a Scale | Standard Deviation 26.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Financial Difficulties | -1.0 Units on a Scale | Standard Deviation 27.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Financial Difficulties | -5.2 Units on a Scale | Standard Deviation 28.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Financial Difficulties | -6.8 Units on a Scale | Standard Deviation 28.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Insomnia | 24.9 Units on a Scale | Standard Deviation 27.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Appetite Loss | 10.8 Units on a Scale | Standard Deviation 26.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Insomnia | 1.1 Units on a Scale | Standard Deviation 30.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Insomnia | 2.7 Units on a Scale | Standard Deviation 30.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Insomnia | -2.3 Units on a Scale | Standard Deviation 29.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Insomnia | -2.9 Units on a Scale | Standard Deviation 30.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Insomnia | -16.7 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Nausea/Vomiting | 2.3 Units on a Scale | Standard Deviation 7.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Nausea/Vomiting | 10.5 Units on a Scale | Standard Deviation 17.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Nausea/Vomiting | 7.5 Units on a Scale | Standard Deviation 16.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Nausea/Vomiting | 5.2 Units on a Scale | Standard Deviation 13.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Nausea/Vomiting | 3.7 Units on a Scale | Standard Deviation 12.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Nausea/Vomiting | 3.2 Units on a Scale | Standard Deviation 13.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Nausea/Vomiting | 2.8 Units on a Scale | Standard Deviation 11.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Nausea/Vomiting | 3.0 Units on a Scale | Standard Deviation 12.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Nausea/Vomiting | -8.3 Units on a Scale | Standard Deviation 11.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Pain | 16.4 Units on a Scale | Standard Deviation 20 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Pain | 1.1 Units on a Scale | Standard Deviation 22.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Pain | 2.8 Units on a Scale | Standard Deviation 23.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Pain | 2.5 Units on a Scale | Standard Deviation 22.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Pain | 3.8 Units on a Scale | Standard Deviation 23.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Pain | 5.7 Units on a Scale | Standard Deviation 24.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Pain | 5.1 Units on a Scale | Standard Deviation 24.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Pain | 1.4 Units on a Scale | Standard Deviation 22.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Pain | 0.5 Units on a Scale | Standard Deviation 21.5 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Pain | -25.0 Units on a Scale | Standard Deviation 35.4 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Cognitive Functioning | 88.7 Units on a Scale | Standard Deviation 16.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Cognitive Functioning | -6.9 Units on a Scale | Standard Deviation 19.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Cognitive Functioning | -6.8 Units on a Scale | Standard Deviation 19.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Cognitive Functioning | -6.9 Units on a Scale | Standard Deviation 19.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Cognitive Functioning | -7.3 Units on a Scale | Standard Deviation 20.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Cognitive Functioning | -7.6 Units on a Scale | Standard Deviation 20.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Cognitive Functioning | -8.1 Units on a Scale | Standard Deviation 20.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Cognitive Functioning | -8.4 Units on a Scale | Standard Deviation 20.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Cognitive Functioning | -6.1 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Cognitive Functioning | -6.0 Units on a Scale | Standard Deviation 20.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Cognitive Functioning | 16.7 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 1: Emotional Functioning | 0.0 Units on a Scale | Standard Deviation 19.2 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Emotional Functioning | 1.6 Units on a Scale | Standard Deviation 19.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Emotional Functioning | 2.2 Units on a Scale | Standard Deviation 19.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 4: Emotional Functioning | 2.8 Units on a Scale | Standard Deviation 20 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 5: Emotional Functioning | 2.6 Units on a Scale | Standard Deviation 21.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 9: Emotional Functioning | 2.9 Units on a Scale | Standard Deviation 21.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 14: Emotional Functioning | 2.5 Units on a Scale | Standard Deviation 21.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Emotional Functioning | 3.1 Units on a Scale | Standard Deviation 21.3 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Emotional Functioning | 6.1 Units on a Scale | Standard Deviation 21.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 12: Emotional Functioning | 6.5 Units on a Scale | Standard Deviation 21.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Emotional Functioning | 12.5 Units on a Scale | Standard Deviation 17.7 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at EoT: Role Functioning | -3.5 Units on a Scale | Standard Deviation 24.9 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 6: Role Functioning | 2.4 Units on a Scale | Standard Deviation 24.1 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at FU Month 18: Role Functioning | 8.3 Units on a Scale | Standard Deviation 11.8 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline: Social Functioning | 83.2 Units on a Scale | Standard Deviation 21.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 2: Social Functioning | -4.1 Units on a Scale | Standard Deviation 23.6 |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Change at Cycle 3: Social Functioning | -3.3 Units on a Scale | Standard Deviation 24.4 |
IDFS Plus Second Primary Non-Breast Cancer
IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site).
Time frame: Baseline up to approximately 70 months
Population: The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | IDFS Plus Second Primary Non-Breast Cancer | 93.43 Percent Probability |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | IDFS Plus Second Primary Non-Breast Cancer | 92.26 Percent Probability |
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: First participant randomized up to approximately 7.5 years
Population: The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Overall Survival (OS) | 96.03 Percent Probability |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Overall Survival (OS) | 94.86 Percent Probability |
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0).
Time frame: From randomization to approximately 7.5 years
Population: The safety population included all randomized participants who received at least one full or partial dose of any study treatment. 8 participants were randomized but did not receive any study treatment (5 in the Anthracycline, Trastuzumab, Pertuzumab, and Taxane \[AC-THP\] arm, 3 in the Anthracycline, Trastuzumab Emtansine and Pertuzumab \[AC-KP\] arm). 16 participants in the AC-THP and 13 participants in the AC-KP arm only received AC but no HER2 targeted therapy and were assigned to the AC-THP arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Percentage of Participants With Adverse Events | 98.5 Percentage of participants |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Percentage of Participants With Adverse Events | 99.1 Percentage of participants |
Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.
Time frame: First participant randomized up to approximately 7.5 years.
Population: The safety population included all randomized participants who received at least one full or partial dose of any study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Decrease from baseline <10 Ejection Fraction (EF) points | 506 Participants |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Absolute value >= 50% and decrease from baseline >= 10 EF points | 254 Participants |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Absolute value < 50% and decrease from baseline >= 10 EF points | 71 Participants |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Absolute value < 50% and decrease from baseline >= 15 EF points | 61 Participants |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Absolute value < 50% and decrease from baseline >= 15 EF points | 28 Participants |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Decrease from baseline <10 Ejection Fraction (EF) points | 522 Participants |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Absolute value < 50% and decrease from baseline >= 10 EF points | 35 Participants |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | Absolute value >= 50% and decrease from baseline >= 10 EF points | 245 Participants |
Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment
The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning.
Time frame: From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above.
Population: The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. This subset population includes only participants who received HER2-targeted therapy.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | GHS/QoL Score | 2.73 months |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | Physical Function | 25.53 months |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | Role Function | 2.23 months |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | Cognitive Function | 5.49 months |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | Cognitive Function | 9.46 months |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | GHS/QoL Score | 13.57 months |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | Role Function | 9.92 months |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | Physical Function | NA months |