Breast Cancer
Conditions
Keywords
recurrent breast cancer, HER2-positive breast cancer, stage IV breast cancer
Brief summary
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.
Detailed description
Subjects were stratified by * Prior (neo) adjuvant HER2/neu targeted therapy (yes, no) * Prior (neo) adjuvant taxane chemotherapy (yes, no) * Planned taxane treatment (once weekly paclitaxel versus docetaxel once every 3 weeks) * Liver metastasis (yes, no) Subjects were randomized 1:1 to the following treatments to a planned sample size of approximately 600 subjects (to achieve 536 centrally confirmed HER2 positive subjects): * Taxane based chemotherapy plus lapatinib for 24 weeks followed by single agent lapatinib * Taxane based chemotherapy plus trastuzumab for 24 weeks followed by single agent trastuzumab The choice of taxane (once weekly paclitaxel versus docetaxel once every 3 weeks) was at the discretion of the treating physician and was specified at the time of subject randomization. A protocol-specified interim analysis was conducted on 27-Apr-2012, following which the participants in the Lapatinib plus taxane based chemotherapy arm could cross over to Taxane based chemotherapy plus Trastuzumab.
Interventions
BIOLOGICALtrastuzumab
IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).
DRUGdocetaxel
75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).
DRUGlapatinib ditosylate
1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).
DRUGpaclitaxel
80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.
Sponsors
NCIC Clinical Trials Group
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: * Histologically confirmed adenocarcinoma of the breast. * MBC (stage IV) at primary diagnosis or at relapse after curative intent therapy. * Local or central laboratory confirmed HER2/neu overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by: 1. 3+ over expression by immunohistochemistry (IHC) (\>30% of invasive tumour cells); 2. 2+ or 3+ (in 30% or less neoplastic cells) overexpression by IHC analysis AND fluorescence or chromogenic in situ hybridization (FISH/CISH) test demonstrating HER2/neu gene amplification; 3. HER2/neu gene amplification by FISH/CISH \[\>6 HER2/neu gene copies per nucleus, or a FISH/CISH ratio (HER2 gene copies to chromosome 17 signals) of \>=2.2\] * Subjects must have had evidence of metastatic disease, but measurable disease was not mandatory. To be considered evaluable for overall response rate (CR and PR), subjects must have had at least 1 measurable lesion as follows: 1. X-ray, physical exam \>=20 mm. 2. Conventional computed tomography (CT) scan, magnetic resonance imaging (MRI) \>=20 mm. 3. Spiral CT scan \>=10 mm. Key
Exclusion criteria
* Subjects with a history of other malignancies, except: adequately treated ductal carcinoma in-situ or lobular carcinoma in-situ, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor (non-breast) curatively treated with no evidence of disease for \>=5 years. * Subjects who had received prior chemotherapy, immunotherapy, biologic therapy or HER2/neu targeted therapy for recurrent or MBC. * Subjects receiving ongoing anti-cancer treatment or other investigational anti-cancer agents for breast cancer or subjects who had used an investigational drug within 30 days or 5 half-lives (if known), whichever was longer, preceding the date of randomization. * Subjects with: CNS metastases (including leptomeningeal involvement), serious cardiac illness, peripheral neuropathy grade 2 or greater, subjects with gastrointestinal tract disease, subjects receiving CYP3A4 inhibitors or inducers, and subjects with history of allergic or hypersensitivity reactions to any study drug or their excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) at the Time of Primary Results | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) (IIT Population) | From date of randomization until date of death from any cause, assessed up approximately 165 months | Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover. |
| Overall Survival (OS) (Central HER2+ Population) | From date of randomization until date of death from any cause, assessed up approximately 165 months | Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover. |
| Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects. |
| Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects. |
| Time to Central Nervous System (CNS) Metastasis (IIT Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover. |
| Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover. |
| Overall Response Rate (ORR) (IIT Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: * Complete Response (CR): Disappearance of all target and non-target lesions. * Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the Baseline sum LD. * Overall Response (OR): CR + PR. |
| Overall Response Rate (ORR) (Central HER2+ Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: * Complete Response (CR): Disappearance of all target and non-target lesions. * Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the Baseline sum LD. * Overall Response (OR): CR + PR. |
| Clinical Benefit Response (CBR) (IIT Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Clinical Benefit Response (CBR) was defined as the percentage with evidence of Complete Response (CR), Partial Response (PR) (participants with at least 1 measurable lesion at baseline), or maintaining Stable Disease (SD) for at least 24 weeks (all subjects, with or without measurable disease at baseline) while on study, according to the investigator assessment of response per RECIST 1.1 criteria. Participants were considered to be positive (Yes) for CBR if they experienced any CR or PR for any duration prior to progressive disease. Participants were considered to be negative (No) for CBR if they had progressive disease prior to Week 24 without prior confirmed CR or PR. |
| Clinical Benefit Response (CBR) (Central HER2+ Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Clinical Benefit Response (CBR) was defined as the percentage with evidence of Complete Response (CR), Partial Response (PR) (participants with at least 1 measurable lesion at baseline), or maintaining Stable Disease (SD) for at least 24 weeks (all subjects, with or without measurable disease at baseline) while on study, according to the investigator assessment of response per RECIST 1.1 criteria. Participants were considered to be positive (Yes) for CBR if they experienced any CR or PR for any duration prior to progressive disease. Participants were considered to be negative (No) for CBR if they had progressive disease prior to Week 24 without prior confirmed CR or PR. |
| Time to Response (TTR) (IIT Population) | From date of randomization until date of first response, assessed up approximately 45 months | Time to Response was defined as the time from randomization to the earliest date of Complete Response (CR) or Partial Response (PR). The event of first response was the first CR or PR; censoring was at PD date for those who progressed or at the last RECIST date if no progression occurred. |
| Time to Response (TTR) (Central HER2+ Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Time to Response was defined as the time from randomization to the earliest date of Complete Response (CR) or Partial Response (PR). The event of first response was the first CR or PR; censoring was at PD date for those who progressed or at the last RECIST date if no progression occurred. |
| Progression Free Survival (PFS) at the Time of Final Analysis | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months | Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at the last PFS assessment before crossover. |
| Duration of Response (DoR) (Central HER2+ Population) | From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months | Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented sign of Progressive Disease or Death, with censoring at the last RECIST date if no progression occurred. |
| EORTC QLQ-C30 Global Score at 12 Weeks | Week 12 | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQC-30) is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life. |
| Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144 | The European Quality of Life (EuroQol) - 5 Domain (EQ-5D) self-administered questionnaire consists of two pages comprising the EQ-5D descriptive system and the EQ Visual Analogue Scale (VAS). The EQ-5D descriptive system comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and each dimension comprises three levels (no problems, some problems, extreme problems, unable to perform the activity). |
| Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144 | The European Quality of Life (EuroQol) - 5 Domain (EQ-5D) self-administered questionnaire consists of two pages comprising the EQ-5D descriptive system and the EQ Visual Analogue Scale (VAS). The EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). |
| Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only) | From date of randomization till 28 days safety follow-up, assessed up to 40 months | The measures of healthcare resource utilization collected were categorized: hospitalization/inpatient visit, Institutionalized, Outpatient visit. |
| Number of Participant Hospitalized (Canadian and Australian Centers Only) | From date of randomization till 28 days safety follow-up, assessed up to 40 months | The number of hospitalizations were categorized: \>0 and =\<2, \>2 and =\<4 and \>4. |
| Total and Average Duration of Hospitalization (Canadian and Australian Centers Only) | From date of randomization till 28 days safety follow-up, assessed up to 40 months | The total duration of hospitalization in days and average duration of each hospitalization in days were summarized using descriptive statistics. |
| Reasons for Hospitalization (Canadian and Australian Centers Only) | From date of randomization till 28 days safety follow-up, assessed up to 40 months | The reasons for hospitalization were categorized: Breast Cancer, Febrile Neutropenia, Infection, Other and Pneumonia. |
| Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | From date of randomization till 28 days safety follow-up, assessed up to 40 months | The type of ward (hospital unit) were categorized: general ward, intensive care unit, oncology ward, rehabilitation unit and other. |
| Discharge Destinations (Canadian and Australian Centers Only) | From date of randomization till 28 days safety follow-up, assessed up to 40 months | The discharge destinations were categorized: died, home, rehabilitation facility and transfer to other hospital. |
| Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status | Up to approximately 39 months | Immunohistochemistry (IHC) analysis of estrogen receptor (ER) and progesterone receptor (PgR) were performed as part of the mandatory central laboratory testing for protocol-specified biomarkers. |
| Duration of Response (DoR) (IIT Population) | From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months | Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented sign of Progressive Disease or Death, with censoring at the last RECIST date if no progression occurred. |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted at 167 centers in 21 countries: Argentina (7), Australia (9), Belgium (3), Canada (19), France (5), Germany (23), India (3), Israel (4), Italy (7), Japan (12), Republic of Korea (4), Mexico (3), Netherlands (4), Poland (5), Russian Federation (7), Spain (14), Taiwan (4), Thailand (2), Ukraine (3), United Kingdom (18), United States (11).
Participants by arm
| Arm | Count |
|---|---|
| Lapatinib (LTax/L) Lapatinib 1250 mg once daily. Taxane based chemotherapy: Paclitaxel 80 mg/m2 IV once weekly (Days 1, 8, and 15 of a 4-week cycle) OR Docetaxel 75 mg/m2 IV once every 3 weeks (Day 1 of a 3-week cycle) plus G-CSF: according to institutional standards. Followed by Lapatinib 1500 mg once daily until disease progression. | 326 |
| Trastuzumab (TTax/T) Trastuzumab IV once weekly (loading dose 4 mg/kg, subsequent doses 2 mg/kg) and Paclitaxel 80 mg/m2 IV once weekly (Days 1, 8, and 15 of a 4-week cycle) OR Trastuzumab IV once every 3 weeks (loading dose 8 mg/kg, subsequent doses 6 mg/kg) and Docetaxel 75 mg/m2 IV once every 3 weeks (Day 1 of a 3-week cycle). Followed by Trastuzumab 6 mg/kg IV once every 3 weeks until disease progression. | 326 |
| Total | 652 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 11 |
| Overall Study | Disease progression | 232 | 203 |
| Overall Study | Intercurrent illness | 5 | 6 |
| Overall Study | Primary reason for withdrawal = missing | 1 | 1 |
| Overall Study | Randomized not Treated | 4 | 1 |
| Overall Study | Refused further treatment (not due to toxicity) | 8 | 7 |
| Overall Study | Subject Reached Protocol-Defined Stopping Criteria | 18 | 70 |
| Overall Study | Symptomatic progression | 8 | 4 |
| Overall Study | Toxicity | 44 | 23 |
Baseline characteristics
| Characteristic | Lapatinib (LTax/L) | Trastuzumab (TTax/T) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 66 Participants | 63 Participants | 129 Participants |
| Age, Categorical Between 18 and 65 years | 260 Participants | 263 Participants | 523 Participants |
| Age, Continuous | 55.4 years | 54.4 years | 54.9 years |
| Central review estrogen receptor (ER) status Missing | 17 Participants | 11 Participants | 28 Participants |
| Central review estrogen receptor (ER) status Negative | 96 Participants | 107 Participants | 203 Participants |
| Central review estrogen receptor (ER) status Positive (>0) | 213 Participants | 208 Participants | 421 Participants |
| Central review human epidermal growth factor receptor 2 (HER2) status Equivocal Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH) | 9 Participants | 5 Participants | 14 Participants |
| Central review human epidermal growth factor receptor 2 (HER2) status Negative Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH) | 36 Participants | 46 Participants | 82 Participants |
| Central review human epidermal growth factor receptor 2 (HER2) status Positive Immunohistochemistry (IHC) or Fluorescence in situ hybridization (FISH) | 270 Participants | 267 Participants | 537 Participants |
| Central review human epidermal growth factor receptor 2 (HER2) status Unknown | 11 Participants | 8 Participants | 19 Participants |
| Central Review of Antigen KI-67 (ki67) | 33.33 % cells positive | 31.43 % cells positive | 32.37 % cells positive |
| Central Review of Cytokeratin 5 (CK5) Status Missing | 58 Participants | 67 Participants | 125 Participants |
| Central Review of Cytokeratin 5 (CK5) Status Negative | 210 Participants | 218 Participants | 428 Participants |
| Central Review of Cytokeratin 5 (CK5) Status Positive (>0) | 58 Participants | 41 Participants | 99 Participants |
| Central Review of epidermal growth factor receptor (EGFR) Status Missing | 61 Participants | 68 Participants | 129 Participants |
| Central Review of epidermal growth factor receptor (EGFR) Status Negative | 194 Participants | 181 Participants | 375 Participants |
| Central Review of epidermal growth factor receptor (EGFR) Status Positive (>0) | 71 Participants | 77 Participants | 148 Participants |
| Central review progesterone receptor (PgR) status Missing | 20 Participants | 18 Participants | 38 Participants |
| Central review progesterone receptor (PgR) status Negative | 190 Participants | 204 Participants | 394 Participants |
| Central review progesterone receptor (PgR) status Positive (>0) | 116 Participants | 104 Participants | 220 Participants |
| Disease Status Missing | 1 Participants | 1 Participants | 2 Participants |
| Disease Status Primary diagnosis | 138 Participants | 138 Participants | 276 Participants |
| Disease Status Progression after therapy | 187 Participants | 187 Participants | 374 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 34 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 288 Participants | 283 Participants | 571 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 13 Participants |
| Liver metastasis No | 177 Participants | 176 Participants | 353 Participants |
| Liver metastasis Yes | 149 Participants | 150 Participants | 299 Participants |
| Number of Participants with the Indicated Eastern Cooperative Oncology Group Performance Status 0, fully active | 196 Participants | 204 Participants | 400 Participants |
| Number of Participants with the Indicated Eastern Cooperative Oncology Group Performance Status 1, ambulatory, restricted strenuous activity | 118 Participants | 112 Participants | 230 Participants |
| Number of Participants with the Indicated Eastern Cooperative Oncology Group Performance Status 2, ambulatory, no work activity | 12 Participants | 10 Participants | 22 Participants |
| Planned taxane treatment 3-weekly docetaxel | 180 Participants | 180 Participants | 360 Participants |
| Planned taxane treatment Weekly paclitaxel | 146 Participants | 146 Participants | 292 Participants |
| Prior (neo)adjuvant HER2 targeted therapy No | 267 Participants | 267 Participants | 534 Participants |
| Prior (neo)adjuvant HER2 targeted therapy Yes | 59 Participants | 59 Participants | 118 Participants |
| Prior neoadjuvant/Metastatic endocrine therapy Missing | 0 Participants | 1 Participants | 1 Participants |
| Prior neoadjuvant/Metastatic endocrine therapy No | 204 Participants | 198 Participants | 402 Participants |
| Prior neoadjuvant/Metastatic endocrine therapy Yes | 122 Participants | 127 Participants | 249 Participants |
| Prior neoadjuvant/Metastatic radiotherapy Missing | 1 Participants | 1 Participants | 2 Participants |
| Prior neoadjuvant/Metastatic radiotherapy No | 187 Participants | 176 Participants | 363 Participants |
| Prior neoadjuvant/Metastatic radiotherapy Yes | 138 Participants | 149 Participants | 287 Participants |
| Prior (neo)adjuvant taxane chemotherapy No | 261 Participants | 257 Participants | 518 Participants |
| Prior (neo)adjuvant taxane chemotherapy Yes | 65 Participants | 69 Participants | 134 Participants |
| Prior neoadjuvant therapy/Anthracyclines No | 198 Participants | 186 Participants | 384 Participants |
| Prior neoadjuvant therapy/Anthracyclines Yes | 128 Participants | 140 Participants | 268 Participants |
| Prior neoadjuvant therapy/Other chemotherapy No | 180 Participants | 165 Participants | 345 Participants |
| Prior neoadjuvant therapy/Other chemotherapy Yes | 146 Participants | 161 Participants | 307 Participants |
| Prior neoadjuvant therapy/Other therapy Missing | 0 Participants | 1 Participants | 1 Participants |
| Prior neoadjuvant therapy/Other therapy No | 321 Participants | 323 Participants | 644 Participants |
| Prior neoadjuvant therapy/Other therapy Yes | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 67 Participants | 74 Participants | 141 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 246 Participants | 234 Participants | 480 Participants |
| Region of Enrollment Argentina | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment Australia | 17 Participants | 13 Participants | 30 Participants |
| Region of Enrollment Belgium | 3 Participants | 6 Participants | 9 Participants |
| Region of Enrollment Canada | 39 Participants | 36 Participants | 75 Participants |
| Region of Enrollment France | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment Germany | 32 Participants | 34 Participants | 66 Participants |
| Region of Enrollment India | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment Israel | 16 Participants | 15 Participants | 31 Participants |
| Region of Enrollment Italy | 5 Participants | 8 Participants | 13 Participants |
| Region of Enrollment Japan | 22 Participants | 20 Participants | 42 Participants |
| Region of Enrollment Korea, Republic of | 17 Participants | 19 Participants | 36 Participants |
| Region of Enrollment Mexico | 3 Participants | 6 Participants | 9 Participants |
| Region of Enrollment Netherlands | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment Poland | 7 Participants | 12 Participants | 19 Participants |
| Region of Enrollment Russian Federation | 55 Participants | 46 Participants | 101 Participants |
| Region of Enrollment Spain | 19 Participants | 19 Participants | 38 Participants |
| Region of Enrollment Taiwan | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment Thailand | 9 Participants | 12 Participants | 21 Participants |
| Region of Enrollment Ukraine | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment United Kingdom | 33 Participants | 32 Participants | 65 Participants |
| Region of Enrollment United States | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Female | 326 Participants | 326 Participants | 652 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 21 / 326 | 13 / 326 | 0 / 5 | 82 / 301 | 73 / 312 | 0 / 5 |
| other Total, other adverse events | 316 / 322 | 319 / 325 | 1 / 5 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 106 / 322 | 66 / 325 | 2 / 5 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Progression Free Survival (PFS) at the Time of Primary Results
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
Population: Intent-to-Treat (ITT) and centrally-confirmed HER2 positive populations
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lapatinib (LTax/L) | Progression Free Survival (PFS) at the Time of Primary Results | Intent-to-Treat (ITT) population | 8.97 Months |
| Lapatinib (LTax/L) | Progression Free Survival (PFS) at the Time of Primary Results | centrally-confirmed HER2 positive population | 9.13 Months |
| Trastuzumab (TTax/T) | Progression Free Survival (PFS) at the Time of Primary Results | Intent-to-Treat (ITT) population | 11.30 Months |
| Trastuzumab (TTax/T) | Progression Free Survival (PFS) at the Time of Primary Results | centrally-confirmed HER2 positive population | 13.63 Months |
Comparison: PFS at the time of Primary Analysis (IIT population)p-value: 0.00195% CI: [1.133, 1.648]Log Rank
Comparison: PFS at the time of Primary Analysis (Central HER2+ population)p-value: 0.000295% CI: [1.204, 1.829]Log Rank
Secondary
Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only)
The European Quality of Life (EuroQol) - 5 Domain (EQ-5D) self-administered questionnaire consists of two pages comprising the EQ-5D descriptive system and the EQ Visual Analogue Scale (VAS). The EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0).
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144
Population: Safety Set - Canadian and Australian centers only. At each time point, only participants with a value at both Baseline and post-baseline time points were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 36 | 0.4 Score on a scale | Standard Deviation 21.86 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 72 | 10.1 Score on a scale | Standard Deviation 7.36 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 84 | 5.2 Score on a scale | Standard Deviation 6.46 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 24 | -1.5 Score on a scale | Standard Deviation 21.98 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 96 | 3.0 Score on a scale | Standard Deviation 19.9 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 48 | 5.2 Score on a scale | Standard Deviation 23.17 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 120 | 10.3 Score on a scale | Standard Deviation 5.91 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 12 | 1.6 Score on a scale | Standard Deviation 17.16 |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 144 | 13.0 Score on a scale | — |
| Lapatinib (LTax/L) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 60 | 5.8 Score on a scale | Standard Deviation 10.51 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 144 | 4.0 Score on a scale | — |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 12 | 7.0 Score on a scale | Standard Deviation 19.3 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 24 | 1.3 Score on a scale | Standard Deviation 21.56 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 36 | 5.9 Score on a scale | Standard Deviation 22.53 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 48 | 6.5 Score on a scale | Standard Deviation 25.37 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 60 | 7.9 Score on a scale | Standard Deviation 28.29 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 84 | 4.9 Score on a scale | Standard Deviation 25.08 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 96 | -10.0 Score on a scale | Standard Deviation 10.8 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 120 | -11.0 Score on a scale | Standard Deviation 13.11 |
| Trastuzumab (TTax/T) | Change From Baseline in the EQ-VAS Score (Canadian and Australian Centers Only) | Week 72 | 11.8 Score on a scale | Standard Deviation 29.96 |
Secondary
Clinical Benefit Response (CBR) (Central HER2+ Population)
Clinical Benefit Response (CBR) was defined as the percentage with evidence of Complete Response (CR), Partial Response (PR) (participants with at least 1 measurable lesion at baseline), or maintaining Stable Disease (SD) for at least 24 weeks (all subjects, with or without measurable disease at baseline) while on study, according to the investigator assessment of response per RECIST 1.1 criteria. Participants were considered to be positive (Yes) for CBR if they experienced any CR or PR for any duration prior to progressive disease. Participants were considered to be negative (No) for CBR if they had progressive disease prior to Week 24 without prior confirmed CR or PR.
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Population: Centrally-confirmed HER2 positive population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lapatinib (LTax/L) | Clinical Benefit Response (CBR) (Central HER2+ Population) | 61.1 Percentage of Participants |
| Trastuzumab (TTax/T) | Clinical Benefit Response (CBR) (Central HER2+ Population) | 65.2 Percentage of Participants |
Secondary
Clinical Benefit Response (CBR) (IIT Population)
Clinical Benefit Response (CBR) was defined as the percentage with evidence of Complete Response (CR), Partial Response (PR) (participants with at least 1 measurable lesion at baseline), or maintaining Stable Disease (SD) for at least 24 weeks (all subjects, with or without measurable disease at baseline) while on study, according to the investigator assessment of response per RECIST 1.1 criteria. Participants were considered to be positive (Yes) for CBR if they experienced any CR or PR for any duration prior to progressive disease. Participants were considered to be negative (No) for CBR if they had progressive disease prior to Week 24 without prior confirmed CR or PR.
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Population: Intent-to-Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lapatinib (LTax/L) | Clinical Benefit Response (CBR) (IIT Population) | 60.4 Percentage of Participants |
| Trastuzumab (TTax/T) | Clinical Benefit Response (CBR) (IIT Population) | 62.0 Percentage of Participants |
Secondary
Discharge Destinations (Canadian and Australian Centers Only)
The discharge destinations were categorized: died, home, rehabilitation facility and transfer to other hospital.
Time frame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
Population: Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | Discharge Destinations (Canadian and Australian Centers Only) | Home | 26 Participants |
| Lapatinib (LTax/L) | Discharge Destinations (Canadian and Australian Centers Only) | Transfer to other hospital | 1 Participants |
| Lapatinib (LTax/L) | Discharge Destinations (Canadian and Australian Centers Only) | Rehabilitation facility | 0 Participants |
| Lapatinib (LTax/L) | Discharge Destinations (Canadian and Australian Centers Only) | Unknwon/missing | 1 Participants |
| Lapatinib (LTax/L) | Discharge Destinations (Canadian and Australian Centers Only) | Died | 1 Participants |
| Trastuzumab (TTax/T) | Discharge Destinations (Canadian and Australian Centers Only) | Unknwon/missing | 0 Participants |
| Trastuzumab (TTax/T) | Discharge Destinations (Canadian and Australian Centers Only) | Died | 1 Participants |
| Trastuzumab (TTax/T) | Discharge Destinations (Canadian and Australian Centers Only) | Home | 14 Participants |
| Trastuzumab (TTax/T) | Discharge Destinations (Canadian and Australian Centers Only) | Rehabilitation facility | 1 Participants |
| Trastuzumab (TTax/T) | Discharge Destinations (Canadian and Australian Centers Only) | Transfer to other hospital | 1 Participants |
Secondary
Duration of Response (DoR) (Central HER2+ Population)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented sign of Progressive Disease or Death, with censoring at the last RECIST date if no progression occurred.
Time frame: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months
Population: Centrally-confirmed HER2 positive population. Subset of participants with at least one measurable lesion at baseline achieving either a confirmed complete response (CR) or partial response (PR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Duration of Response (DoR) (Central HER2+ Population) | 8.3 Months |
| Trastuzumab (TTax/T) | Duration of Response (DoR) (Central HER2+ Population) | 11.1 Months |
Comparison: Duration of Response (DoR) (Central HER2+ population)95% CI: [1.1767, 2.0666]
Secondary
Duration of Response (DoR) (IIT Population)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented sign of Progressive Disease or Death, with censoring at the last RECIST date if no progression occurred.
Time frame: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 165 months
Population: Intent-to-Treat (ITT) Population. Subset of participants with at least one measurable lesion at baseline achieving either a confirmed complete response (CR) or partial response (PR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Duration of Response (DoR) (IIT Population) | 8.3 Months |
| Trastuzumab (TTax/T) | Duration of Response (DoR) (IIT Population) | 11.1 Months |
Comparison: Duration of Response (DoR) (IIT population)95% CI: [1.1479, 1.9251]
Secondary
EORTC QLQ-C30 Global Score at 12 Weeks
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQC-30) is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life.
Time frame: Week 12
Population: Participants in the safety population with available data for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lapatinib (LTax/L) | EORTC QLQ-C30 Global Score at 12 Weeks | 61.67 Score on global scale | Standard Deviation 20.93 |
| Trastuzumab (TTax/T) | EORTC QLQ-C30 Global Score at 12 Weeks | 64.41 Score on global scale | Standard Deviation 20.18 |
Secondary
Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status
Immunohistochemistry (IHC) analysis of estrogen receptor (ER) and progesterone receptor (PgR) were performed as part of the mandatory central laboratory testing for protocol-specified biomarkers.
Time frame: Up to approximately 39 months
Population: Intent-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib (LTax/L) | Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status | estrogen receptor (ER) positive | 65 Percentage of Participants |
| Lapatinib (LTax/L) | Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status | progesterone receptor (PgR) negative | 58 Percentage of Participants |
| Trastuzumab (TTax/T) | Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status | estrogen receptor (ER) positive | 64 Percentage of Participants |
| Trastuzumab (TTax/T) | Estrogen Receptor (ER) and Progesterone Receptor (PgR) Status | progesterone receptor (PgR) negative | 63 Percentage of Participants |
Secondary
Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population)
The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects.
Time frame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
Population: Participants in the centrally-confirmed HER2 positive population with available data for the outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = No | 128 Participants |
| Lapatinib (LTax/L) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Yes | 43 Participants |
| Lapatinib (LTax/L) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Unknown | 53 Participants |
| Trastuzumab (TTax/T) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Yes | 50 Participants |
| Trastuzumab (TTax/T) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = No | 92 Participants |
| Trastuzumab (TTax/T) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Unknown | 44 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Yes | 1 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Unknown | 0 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = No | 3 Participants |
| Overall TTax/T | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = No | 95 Participants |
| Overall TTax/T | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Yes | 51 Participants |
| Overall TTax/T | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | Subject had CNS metastasis at first progression = Unknown | 44 Participants |
Secondary
Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population)
The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects.
Time frame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
Population: Participants in the Intent-to-Treat (ITT) population with available data for the outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Yes | 47 Participants |
| Lapatinib (LTax/L) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Unknown | 66 Participants |
| Lapatinib (LTax/L) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = No | 155 Participants |
| Trastuzumab (TTax/T) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Yes | 55 Participants |
| Trastuzumab (TTax/T) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Unknown | 62 Participants |
| Trastuzumab (TTax/T) | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = No | 119 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = No | 4 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Yes | 1 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Unknown | 0 Participants |
| Overall TTax/T | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Yes | 56 Participants |
| Overall TTax/T | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = Unknown | 62 Participants |
| Overall TTax/T | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | Subject had CNS metastasis at first progression = No | 123 Participants |
Secondary
Number of Participant Hospitalized (Canadian and Australian Centers Only)
The number of hospitalizations were categorized: \>0 and =\<2, \>2 and =\<4 and \>4.
Time frame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
Population: Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | Number of Participant Hospitalized (Canadian and Australian Centers Only) | > 0 and =< 2 | 27 Participants |
| Lapatinib (LTax/L) | Number of Participant Hospitalized (Canadian and Australian Centers Only) | > 2 and =< 4 | 1 Participants |
| Lapatinib (LTax/L) | Number of Participant Hospitalized (Canadian and Australian Centers Only) | > 4 | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participant Hospitalized (Canadian and Australian Centers Only) | > 0 and =< 2 | 16 Participants |
| Trastuzumab (TTax/T) | Number of Participant Hospitalized (Canadian and Australian Centers Only) | > 2 and =< 4 | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participant Hospitalized (Canadian and Australian Centers Only) | > 4 | 1 Participants |
Secondary
Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only)
The European Quality of Life (EuroQol) - 5 Domain (EQ-5D) self-administered questionnaire consists of two pages comprising the EQ-5D descriptive system and the EQ Visual Analogue Scale (VAS). The EQ-5D descriptive system comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and each dimension comprises three levels (no problems, some problems, extreme problems, unable to perform the activity).
Time frame: Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144
Population: Safety Set - Canadian and Australian centers only. At each time point, only participants with a value at both Baseline and post-baseline time points were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | No Problems | 29 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Some problems | 16 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | No Problems | 41 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Some problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | No Problems | 16 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Some problems | 25 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Unable to perform the activity | 5 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | No Problems | 16 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Some problems | 28 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Missing | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | No Problems | 24 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Some problems | 20 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Unable to perform the activity | 2 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | No Problems | 26 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Some problems | 14 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | No Problems | 38 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Some problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | No Problems | 18 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Some problems | 22 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | No Problems | 10 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Some problems | 30 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | No Problems | 23 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Some problems | 18 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | No Problems | 21 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Some problems | 10 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | No Problems | 28 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Some problems | 2 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Not Done | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | No Problems | 17 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Some problems | 13 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Not Done | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | No Problems | 9 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Some problems | 18 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Unable to perform the activity | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Not Done | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | No Problems | 18 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Some problems | 12 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Not Done | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | No Problems | 14 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Some problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | No Problems | 18 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | No Problems | 15 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Some problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | No Problems | 6 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Some problems | 11 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | No Problems | 10 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Some problems | 7 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Missing | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | No Problems | 8 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | No Problems | 8 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | No Problems | 7 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Some problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | No Problems | 5 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Some problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | No Problems | 5 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Some problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | No Problems | 7 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Some problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | No Problems | 8 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | No Problems | 7 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Some problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | No Problems | 6 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Some problems | 2 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | No Problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Some problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | No Problems | 5 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Some problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | No Problems | 6 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | No Problems | 5 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Some problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | No Problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Some problems | 2 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | No Problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Some problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | No Problems | 5 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | No Problems | 5 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | No Problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Some problems | 2 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | No Problems | 2 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Some problems | 2 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Unable to perform the activity | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | No Problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Some problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | No Problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | No Problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | No Problems | 4 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | No Problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Some problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | No Problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Some problems | 3 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | No Problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | No Problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | No Problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | No Problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Some problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Not Done | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | No Problems | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Some problems | 1 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Unable to perform the activity | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Missing | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | No Problems | 27 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | No Problems | 13 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Some problems | 9 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Some problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 12 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | No Problems | 32 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Some problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Missing | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 72 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 12 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | No Problems | 22 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | No Problems | 15 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Some problems | 13 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | No Problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | No Problems | 3 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 12 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | No Problems | 16 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Some problems | 4 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Some problems | 20 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | No Problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 72 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 12 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | No Problems | 22 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | No Problems | 8 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Some problems | 14 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Some problems | 7 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 12 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | No Problems | 20 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Some problems | 14 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 96 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 72 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 24 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | No Problems | 31 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | No Problems | 9 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Some problems | 3 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | No Problems | 3 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Some problems | 6 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 24 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | No Problems | 18 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Some problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Some problems | 14 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Unable to perform the activity | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 72 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 24 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | No Problems | 12 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | No Problems | 8 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Some problems | 21 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Some problems | 6 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 24 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | No Problems | 18 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 120 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Some problems | 15 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 96 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 72 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 24 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | No Problems | 26 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | No Problems | 6 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Some problems | 5 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | No Problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Some problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | No Problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 36 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | No Problems | 30 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Some problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 84 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | No Problems | 16 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | No Problems | 8 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Some problems | 14 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 36 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | No Problems | 13 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Some problems | 16 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 120 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Missing | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 84 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 36 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | No Problems | 18 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | No Problems | 5 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Some problems | 13 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | No Problems | 3 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Some problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 36 | Some problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 36 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | No Problems | 18 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Some problems | 9 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 84 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 48 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | No Problems | 26 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | No Problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Some problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 144 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Some problems | 6 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 48 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | No Problems | 16 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 144 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Some problems | 11 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 120 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 84 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 48 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | No Problems | 12 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | No Problems | 4 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Some problems | 14 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | No Problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Some problems | 4 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Missing | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | No Problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 48 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | No Problems | 20 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Some problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Some problems | 6 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Unable to perform the activity | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | No Problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 84 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 48 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | No Problems | 16 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | No Problems | 3 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Some problems | 5 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Some problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 60 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | No Problems | 20 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | No Problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Some problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 120 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Mobility @ Week 96 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 60 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | No Problems | 12 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | No Problems | 5 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Some problems | 7 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | No Problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Unable to perform the activity | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 144 | Some problems | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 60 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | No Problems | 11 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Some problems | 1 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Some problems | 8 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Unable to perform the activity | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 144 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Self-Care @ Week 96 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 60 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | No Problems | 12 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | No Problems | 3 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Some problems | 9 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 144 | Not Done | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Unable to perform the activity | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Usual Activities @ Week 96 | Some problems | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Pain/Discomfort @ Week 120 | Missing | 0 Participants |
| Trastuzumab (TTax/T) | Number of Participants Achieving European Quality of Life (EuroQol) - 5 Domain (EQ-5D) Score (Canadian and Australian Centers Only) | Anxiety/Depression @ Week 60 | Not Done | 0 Participants |
Secondary
Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only)
The measures of healthcare resource utilization collected were categorized: hospitalization/inpatient visit, Institutionalized, Outpatient visit.
Time frame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
Population: Safety Set - Canadian and Australian centers only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only) | Hospitalization/Inpatient visit | 29 Participants |
| Lapatinib (LTax/L) | Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only) | Institutionalized | 0 Participants |
| Lapatinib (LTax/L) | Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only) | Outpatient Visit | 52 Participants |
| Trastuzumab (TTax/T) | Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only) | Hospitalization/Inpatient visit | 17 Participants |
| Trastuzumab (TTax/T) | Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only) | Institutionalized | 2 Participants |
| Trastuzumab (TTax/T) | Number of Participants With Healthcare Utilization (Canadian and Australian Centers Only) | Outpatient Visit | 45 Participants |
Secondary
Overall Response Rate (ORR) (Central HER2+ Population)
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: * Complete Response (CR): Disappearance of all target and non-target lesions. * Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the Baseline sum LD. * Overall Response (OR): CR + PR.
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Population: Centrally-confirmed HER2 positive population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lapatinib (LTax/L) | Overall Response Rate (ORR) (Central HER2+ Population) | 66.7 Percentage of Participants |
| Trastuzumab (TTax/T) | Overall Response Rate (ORR) (Central HER2+ Population) | 67.4 Percentage of Participants |
Secondary
Overall Response Rate (ORR) (IIT Population)
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: * Complete Response (CR): Disappearance of all target and non-target lesions. * Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the Baseline sum LD. * Overall Response (OR): CR + PR.
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Population: Intent-to-Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lapatinib (LTax/L) | Overall Response Rate (ORR) (IIT Population) | 64.2 Percentage of Participants |
| Trastuzumab (TTax/T) | Overall Response Rate (ORR) (IIT Population) | 63.3 Percentage of Participants |
Secondary
Overall Survival (OS) (Central HER2+ Population)
Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover.
Time frame: From date of randomization until date of death from any cause, assessed up approximately 165 months
Population: Centrally-confirmed HER2 positive population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Overall Survival (OS) (Central HER2+ Population) | 30.0 Months |
| Trastuzumab (TTax/T) | Overall Survival (OS) (Central HER2+ Population) | NA Months |
Comparison: Overall Survival (OS) (Central HER2+ population)95% CI: [1.1181, 2.2379]
Secondary
Overall Survival (OS) (IIT Population)
Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover.
Time frame: From date of randomization until date of death from any cause, assessed up approximately 165 months
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Overall Survival (OS) (IIT Population) | 30.0 Months |
| Trastuzumab (TTax/T) | Overall Survival (OS) (IIT Population) | 38.3 Months |
Comparison: Overall Survival (OS) (IIT population)95% CI: [1.0246, 1.8549]
Secondary
Progression Free Survival (PFS) at the Time of Final Analysis
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at the last PFS assessment before crossover.
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months
Population: Intent-to-Treat (ITT) and centrally-confirmed HER2 positive populations
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lapatinib (LTax/L) | Progression Free Survival (PFS) at the Time of Final Analysis | Intent-to-Treat (ITT) population | 9.1 Months |
| Lapatinib (LTax/L) | Progression Free Survival (PFS) at the Time of Final Analysis | centrally-confirmed HER2 positive population | 9.4 Months |
| Trastuzumab (TTax/T) | Progression Free Survival (PFS) at the Time of Final Analysis | Intent-to-Treat (ITT) population | 11.5 Months |
| Trastuzumab (TTax/T) | Progression Free Survival (PFS) at the Time of Final Analysis | centrally-confirmed HER2 positive population | 13.8 Months |
Comparison: PFS at the time of Final Analysis (IIT population)95% CI: [1.1466, 1.6422]
Comparison: PFS at the time of Final Analysis (Central HER2+ population)95% CI: [1.2251, 1.8288]
Secondary
Reasons for Hospitalization (Canadian and Australian Centers Only)
The reasons for hospitalization were categorized: Breast Cancer, Febrile Neutropenia, Infection, Other and Pneumonia.
Time frame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
Population: Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Febrile neutropenia | 10 Participants |
| Lapatinib (LTax/L) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Other | 14 Participants |
| Lapatinib (LTax/L) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Infection | 5 Participants |
| Lapatinib (LTax/L) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Pneumonia | 2 Participants |
| Lapatinib (LTax/L) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Breast Cancer | 3 Participants |
| Trastuzumab (TTax/T) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Pneumonia | 1 Participants |
| Trastuzumab (TTax/T) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Breast Cancer | 3 Participants |
| Trastuzumab (TTax/T) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Febrile neutropenia | 1 Participants |
| Trastuzumab (TTax/T) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Infection | 4 Participants |
| Trastuzumab (TTax/T) | Reasons for Hospitalization (Canadian and Australian Centers Only) | Other | 9 Participants |
Secondary
Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population)
Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover.
Time frame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
Population: Participants in the centrally-confirmed HER2 positive population with available data for the outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population) | NA Months |
| Trastuzumab (TTax/T) | Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population) | NA Months |
Comparison: Time to Central Nervous System (CNS) metastasis (Central HER2+ population)95% CI: [0.7144, 1.6787]
Secondary
Time to Central Nervous System (CNS) Metastasis (IIT Population)
Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover.
Time frame: From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months
Population: Participants in the Intent-to-Treat (ITT) population with available data for the outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Time to Central Nervous System (CNS) Metastasis (IIT Population) | NA Months |
| Trastuzumab (TTax/T) | Time to Central Nervous System (CNS) Metastasis (IIT Population) | NA Months |
Comparison: Time to Central Nervous System (CNS) metastasis (IIT population)95% CI: [0.7271, 1.6389]
Secondary
Time to Response (TTR) (Central HER2+ Population)
Time to Response was defined as the time from randomization to the earliest date of Complete Response (CR) or Partial Response (PR). The event of first response was the first CR or PR; censoring was at PD date for those who progressed or at the last RECIST date if no progression occurred.
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months
Population: Centrally-confirmed HER2 positive population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Time to Response (TTR) (Central HER2+ Population) | 2.9 Months |
| Trastuzumab (TTax/T) | Time to Response (TTR) (Central HER2+ Population) | 2.9 Months |
Comparison: Time to Response (TTR) (Central HER2+ population)95% CI: [0.7544, 1.2148]
Secondary
Time to Response (TTR) (IIT Population)
Time to Response was defined as the time from randomization to the earliest date of Complete Response (CR) or Partial Response (PR). The event of first response was the first CR or PR; censoring was at PD date for those who progressed or at the last RECIST date if no progression occurred.
Time frame: From date of randomization until date of first response, assessed up approximately 45 months
Population: Intent-to-Treat (ITT) Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lapatinib (LTax/L) | Time to Response (TTR) (IIT Population) | 2.9 Months |
| Trastuzumab (TTax/T) | Time to Response (TTR) (IIT Population) | 2.9 Months |
Comparison: Time to Response (TTR) (IIT population)95% CI: [0.809, 1.2586]
Secondary
Total and Average Duration of Hospitalization (Canadian and Australian Centers Only)
The total duration of hospitalization in days and average duration of each hospitalization in days were summarized using descriptive statistics.
Time frame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
Population: Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lapatinib (LTax/L) | Total and Average Duration of Hospitalization (Canadian and Australian Centers Only) | Total duration of hospitalization | 10.38 Days | Standard Deviation 10.63 |
| Lapatinib (LTax/L) | Total and Average Duration of Hospitalization (Canadian and Australian Centers Only) | Average duration of each hospitalization | 6.6 Days | Standard Deviation 5.46 |
| Trastuzumab (TTax/T) | Total and Average Duration of Hospitalization (Canadian and Australian Centers Only) | Total duration of hospitalization | 16.18 Days | Standard Deviation 38.63 |
| Trastuzumab (TTax/T) | Total and Average Duration of Hospitalization (Canadian and Australian Centers Only) | Average duration of each hospitalization | 6.5 Days | Standard Deviation 4.81 |
Secondary
Type of Ward (Hospital Unit) (Canadian and Australian Centers Only)
The type of ward (hospital unit) were categorized: general ward, intensive care unit, oncology ward, rehabilitation unit and other.
Time frame: From date of randomization till 28 days safety follow-up, assessed up to 40 months
Population: Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Intensive care unit | 1 Participants |
| Lapatinib (LTax/L) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Other | 6 Participants |
| Lapatinib (LTax/L) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Oncology ward | 13 Participants |
| Lapatinib (LTax/L) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Rehabilitation unit | 0 Participants |
| Lapatinib (LTax/L) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | General ward | 12 Participants |
| Trastuzumab (TTax/T) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Rehabilitation unit | 1 Participants |
| Trastuzumab (TTax/T) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | General ward | 9 Participants |
| Trastuzumab (TTax/T) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Intensive care unit | 1 Participants |
| Trastuzumab (TTax/T) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Oncology ward | 9 Participants |
| Trastuzumab (TTax/T) | Type of Ward (Hospital Unit) (Canadian and Australian Centers Only) | Other | 3 Participants |
Post Hoc
All Collected Deaths
Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from first dose of study medication to 28 days after last dose of study medication (on-treatment), up to approximately 165 months. Deaths were collected in the post treatment survival follow up from 29 days after last dose of study medication until the end of the study, up to approximately 166 months.
Time frame: Pre-treatment deaths: Up to 1 month prior to treatment. On-treatment deaths: Up to 165 months. Post-treatment deaths: up to 166 months.
Population: Intent-to-Treat (ITT) Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lapatinib (LTax/L) | All Collected Deaths | Pre-treatment deaths | 0 Participants |
| Lapatinib (LTax/L) | All Collected Deaths | On-treatment deaths | 21 Participants |
| Lapatinib (LTax/L) | All Collected Deaths | Post-treatment deaths | 82 Participants |
| Lapatinib (LTax/L) | All Collected Deaths | All deaths | 103 Participants |
| Trastuzumab (TTax/T) | All Collected Deaths | All deaths | 86 Participants |
| Trastuzumab (TTax/T) | All Collected Deaths | Pre-treatment deaths | 0 Participants |
| Trastuzumab (TTax/T) | All Collected Deaths | Post-treatment deaths | 73 Participants |
| Trastuzumab (TTax/T) | All Collected Deaths | On-treatment deaths | 13 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | All Collected Deaths | All deaths | 0 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | All Collected Deaths | On-treatment deaths | 0 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | All Collected Deaths | Post-treatment deaths | 0 Participants |
| Crossed Over to Trastuzumab (TTax/T) After IA Results | All Collected Deaths | Pre-treatment deaths | 0 Participants |