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| ID | Type | Description | Link |
|---|---|---|---|
| CLAP016A2303 | Other Identifier | Novartis | |
| CAN-NCIC-MA31 | Other Grant/Funding Number | NCI US - Physician Data Query | |
| 2007-004568-27 | EudraCT Number | ||
| CDR0000594764 | Other Identifier | PDQ | |
| EGF108919 | Other Identifier | GSK |
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| Name | Class |
|---|---|
| NCIC Clinical Trials Group | NETWORK |
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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.
Subjects were stratified by
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lapatinib | Active Comparator | Plus taxane based chemotherapy |
|
| Trastuzumab | Active Comparator | Plus taxane based chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological | IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anchorage | Alaska | 99508 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25779558 | Result | Gelmon KA, Boyle FM, Kaufman B, Huntsman DG, Manikhas A, Di Leo A, Martin M, Schwartzberg LS, Lemieux J, Aparicio S, Shepherd LE, Dent S, Ellard SL, Tonkin K, Pritchard KI, Whelan TJ, Nomikos D, Nusch A, Coleman RE, Mukai H, Tjulandin S, Khasanov R, Rizel S, Connor AP, Santillana SL, Chapman JA, Parulekar WR. Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31. J Clin Oncol. 2015 May 10;33(14):1574-83. doi: 10.1200/JCO.2014.56.9590. Epub 2015 Mar 16. | |
| 28484925 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| docetaxel | Drug | 75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib). |
|
| lapatinib ditosylate | Drug | 1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion). |
|
| paclitaxel | Drug | 80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles. |
|
| From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months |
| 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. | From date of randomization until date of death from any cause, assessed up approximately 165 months |
| 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. | From date of randomization until date of death from any cause, assessed up approximately 165 months |
| 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. | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
| 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. | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
| 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. | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
| 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. | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
| 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:
| 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) (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:
| 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) (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. | 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) (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. | 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 (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. | From date of randomization until date of first response, assessed up approximately 45 months |
| 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. | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months |
| 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. | 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) (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. | 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 |
| 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. | Week 12 |
| 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). | Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144 |
| 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). | Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144 |
| 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. | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| Number of Participant Hospitalized (Canadian and Australian Centers Only) | The number of hospitalizations were categorized: >0 and =<2, >2 and =<4 and >4. | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| 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. | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| Reasons for Hospitalization (Canadian and Australian Centers Only) | The reasons for hospitalization were categorized: Breast Cancer, Febrile Neutropenia, Infection, Other and Pneumonia. | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| 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. | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| Discharge Destinations (Canadian and Australian Centers Only) | The discharge destinations were categorized: died, home, rehabilitation facility and transfer to other hospital. | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| 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. | Up to approximately 39 months |
| Tucson |
| Arizona |
| 85715 |
| United States |
| Novartis Investigative Site | Hot Springs | Arkansas | 71913 | United States |
| Novartis Investigative Site | Berkeley | California | 94704 | United States |
| Novartis Investigative Site | Highland | California | 92346 | United States |
| Novartis Investigative Site | Montebello | California | 90640 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Novartis Investigative Site | Denver | Colorado | 80204 | United States |
| Novartis Investigative Site | Greenwich | Connecticut | 06830 | United States |
| Novartis Investigative Site | Southington | Connecticut | 06489 | United States |
| Novartis Investigative Site | Stamford | Connecticut | 06902-3628 | United States |
| Novartis Investigative Site | Trumbull | Connecticut | 06611 | United States |
| Novartis Investigative Site | Waterbury | Connecticut | 06708 | United States |
| Novartis Investigative Site | Kissimmee | Florida | 34741 | United States |
| Novartis Investigative Site | Loxahatchee Groves | Florida | 33470 | United States |
| Novartis Investigative Site | New Port Richey | Florida | 34655 | United States |
| Novartis Investigative Site | Augusta | Georgia | 30901 | United States |
| Novartis Investigative Site | Lawrenceville | Georgia | 30046 | United States |
| Novartis Investigative Site | Savannah | Georgia | 31405 | United States |
| Novartis Investigative Site | Post Falls | Idaho | 83854 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60657 | United States |
| Novartis Investigative Site | Oak Lawn | Illinois | 60453 | United States |
| Novartis Investigative Site | Evansville | Indiana | 47713 | United States |
| Novartis Investigative Site | Goshen | Indiana | 46526 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46237 | United States |
| Novartis Investigative Site | Munster | Indiana | 46321 | United States |
| Novartis Investigative Site | New Albany | Indiana | 47150 | United States |
| Novartis Investigative Site | Towson | Maryland | 21204 | United States |
| Novartis Investigative Site | Wheaton | Maryland | 20902 | United States |
| Novartis Investigative Site | Bozeman | Montana | 59715 | United States |
| Novartis Investigative Site | Grand Island | Nebraska | 68803 | United States |
| Novartis Investigative Site | Kearney | Nebraska | 68845 | United States |
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| Novartis Investigative Site | Seattle | Washington | 98109 | United States |
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| Novartis Investigative Site | Wenatchee | Washington | 98801 | United States |
| Novartis Investigative Site | Milwaukee | Wisconsin | 53226 | United States |
| Novartis Investigative Site | Capital Federal | Buenos Aires | C1405CUB | Argentina |
| Novartis Investigative Site | Capital Federal | Buenos Aires | C1426ANZ | Argentina |
| Novartis Investigative Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1280AEB | Argentina |
| Novartis Investigative Site | La Plata | Buenos Aires | B1920CMK | Argentina |
| Novartis Investigative Site | Cipolletti | Río Negro Province | R8324EMB | Argentina |
| Novartis Investigative Site | Viedma | Río Negro Province | R8500ACE | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | 4000 | Argentina |
| Novartis Investigative Site | Santa Fe | 3000 | Argentina |
| Novartis Investigative Site | Garran | Australian Capital Territory | 2606 | Australia |
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| Novartis Investigative Site | Tweed Heads | New South Wales | 2485 | Australia |
| Novartis Investigative Site | Woolloongabba | Queensland | 4102 | Australia |
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| Novartis Investigative Site | Bedford Park | South Australia | 5042 | Australia |
| Novartis Investigative Site | Kurralta Park | South Australia | 5037 | Australia |
| Novartis Investigative Site | Hobart | Tasmania | 7000 | Australia |
| Novartis Investigative Site | Box Hill | Victoria | 3128 | Australia |
| Novartis Investigative Site | Fitzroy | Victoria | 3065 | Australia |
| Novartis Investigative Site | Wodonga | Victoria | 3690 | Australia |
| Novartis Investigative Site | Subiaco | Western Australia | 6008 | Australia |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Jette | 1090 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Namur | 5000 | Belgium |
| Novartis Investigative Site | Edmonton | Alberta | T6G 1Z2 | Canada |
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| Novartis Investigative Site | Surrey | British Columbia | V3V 1Z2 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Novartis Investigative Site | Victoria | British Columbia | V8R 6V5 | Canada |
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| Novartis Investigative Site | Saint John | New Brunswick | E2L 4L2 | Canada |
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| Novartis Investigative Site | Greater Sudbury | Ontario | P3E 5J1 | Canada |
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| Novartis Investigative Site | Newmarket | Ontario | L3Y 2P9 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
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| Novartis Investigative Site | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Novartis Investigative Site | Charlottetown | Prince Edward Island | C1A 8T5 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2W 1S6 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1S 4L8 | Canada |
| Novartis Investigative Site | Regina | Saskatchewan | S4T 7T1 | Canada |
| Novartis Investigative Site | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Novartis Investigative Site | Angers | 49033 | France |
| Novartis Investigative Site | Bordeaux | 33075 | France |
| Novartis Investigative Site | Bordeaux | 33077 | France |
| Novartis Investigative Site | Caen | 14076 | France |
| Novartis Investigative Site | Marseille | 13273 | France |
| Novartis Investigative Site | Metz-Tessy | 74370 | France |
| Novartis Investigative Site | Nantes | 44202 | France |
| Novartis Investigative Site | Paris | 75014 | France |
| Novartis Investigative Site | Strasbourg | 67085 | France |
| Novartis Investigative Site | Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Novartis Investigative Site | Stuttgart | Baden-Wurttemberg | 70190 | Germany |
| Novartis Investigative Site | Coburg | Bavaria | 96450 | Germany |
| Novartis Investigative Site | Eggenfelden | Bavaria | 84307 | Germany |
| Novartis Investigative Site | Fürth | Bavaria | 90766 | Germany |
| Novartis Investigative Site | Regensburg | Bavaria | 93049 | Germany |
| Novartis Investigative Site | Rosenheim | Bavaria | 83022 | Germany |
| Novartis Investigative Site | Weiden | Bavaria | 92637 | Germany |
| Novartis Investigative Site | Fürstenwalde | Brandenburg | 15517 | Germany |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60596 | Germany |
| Novartis Investigative Site | Fulda | Hesse | 36043 | Germany |
| Novartis Investigative Site | Lich | Hesse | 35423 | Germany |
| Novartis Investigative Site | Goslar | Lower Saxony | 38642 | Germany |
| Novartis Investigative Site | Hanover | Lower Saxony | 30559 | Germany |
| Novartis Investigative Site | Leer | Lower Saxony | 26789 | Germany |
| Novartis Investigative Site | Bielefeld | North Rhine-Westphalia | 33611 | Germany |
| Novartis Investigative Site | Bonn | North Rhine-Westphalia | 53113 | Germany |
| Novartis Investigative Site | Coesfeld | North Rhine-Westphalia | 48653 | Germany |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 51067 | Germany |
| Novartis Investigative Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| Novartis Investigative Site | Porta Westfalica | North Rhine-Westphalia | 32457 | Germany |
| Novartis Investigative Site | Troisdorf | North Rhine-Westphalia | 53840 | Germany |
| Novartis Investigative Site | Velbert | North Rhine-Westphalia | 42551 | Germany |
| Novartis Investigative Site | Witten | North Rhine-Westphalia | 58452 | Germany |
| Novartis Investigative Site | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| Novartis Investigative Site | Saarbrücken | Saarland | 66113 | Germany |
| Novartis Investigative Site | Dresden | Saxony | 01127 | Germany |
| Novartis Investigative Site | Halle | Saxony-Anhalt | 06120 | Germany |
| Novartis Investigative Site | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 10367 | Germany |
| Novartis Investigative Site | Brandenburg | 14770 | Germany |
| Novartis Investigative Site | Hamburg | 20095 | Germany |
| Novartis Investigative Site | Hamburg | 22081 | Germany |
| Novartis Investigative Site | Hamburg | 22767 | Germany |
| Novartis Investigative Site | Bangalore | 560038 | India |
| Novartis Investigative Site | Nagpur | 440010 | India |
| Novartis Investigative Site | Pune | 411001 | India |
| Novartis Investigative Site | Beersheba | 84101 | Israel |
| Novartis Investigative Site | Holon | 58100 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Poria – Neve Oved | 15208 | Israel |
| Novartis Investigative Site | Ramat Gan | 52621 | Israel |
| Novartis Investigative Site | Lecce | Apulia | 73100 | Italy |
| Novartis Investigative Site | Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00189 | Italy |
| Novartis Investigative Site | Sora (FR) | Lazio | 03039 | Italy |
| Novartis Investigative Site | Genoa | Liguria | 16132 | Italy |
| Novartis Investigative Site | Sassari | Sardinia | 07100 | Italy |
| Novartis Investigative Site | Prato (PO) | Tuscany | 59100 | Italy |
| Novartis Investigative Site | Chieti | 66100 | Italy |
| Novartis Investigative Site | Aichi | 464-8681 | Japan |
| Novartis Investigative Site | Chiba | 277-8577 | Japan |
| Novartis Investigative Site | Ehime | 791-0280 | Japan |
| Novartis Investigative Site | Kagoshima | 892-0833 | Japan |
| Novartis Investigative Site | Kanagawa | 241-8515 | Japan |
| Novartis Investigative Site | Osaka | 540-0006 | Japan |
| Novartis Investigative Site | Osaka | 565-0871 | Japan |
| Novartis Investigative Site | Saitama | 350-1298 | Japan |
| Novartis Investigative Site | Saitama | 362-0806 | Japan |
| Novartis Investigative Site | Shizuoka | 411-8777 | Japan |
| Novartis Investigative Site | Tokyo | 104-8560 | Japan |
| Novartis Investigative Site | Tokyo | 113-8677 | Japan |
| Novartis Investigative Site | Cuernavaca | Morelos | 62450 | Mexico |
| Novartis Investigative Site | Ciudad Obregón | Sonora | 85000 | Mexico |
| Novartis Investigative Site | Mexico City | CP 14080 | Mexico |
| Novartis Investigative Site | Amsterdam | 1091 AC | Netherlands |
| Novartis Investigative Site | Delft | 2625 AD | Netherlands |
| Novartis Investigative Site | Dordrecht | 3318 AT | Netherlands |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Gdansk | 80-219 | Poland |
| Novartis Investigative Site | Lodz | 93-509 | Poland |
| Novartis Investigative Site | Olsztyn | 10-226 | Poland |
| Novartis Investigative Site | Olsztyn | 10-513 | Poland |
| Novartis Investigative Site | Płock | 09-400 | Poland |
| Novartis Investigative Site | Rzeszów | 35-021 | Poland |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | Warsaw | 04-125 | Poland |
| Novartis Investigative Site | Arkhangelsk | 163045 | Russia |
| Novartis Investigative Site | Ivanovo | 153013 | Russia |
| Novartis Investigative Site | Kazan' | 420029 | Russia |
| Novartis Investigative Site | Kirov | 610021 | Russia |
| Novartis Investigative Site | Lipetsk | 398005 | Russia |
| Novartis Investigative Site | Moscow | 115 478 | Russia |
| Novartis Investigative Site | Ryazan | 390011 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Stavropol | 355047 | Russia |
| Novartis Investigative Site | Ufa | 450054 | Russia |
| Novartis Investigative Site | Gyeonggi-do | 10408 | South Korea |
| Novartis Investigative Site | Gyeonggi-do | 410-769 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 110-744 | South Korea |
| Novartis Investigative Site | Seoul | 120-752 | South Korea |
| Novartis Investigative Site | Songpa-gu, Seoul | 138-736 | South Korea |
| Novartis Investigative Site | A Coruña | 15009 | Spain |
| Novartis Investigative Site | Alcorcón | 28922 | Spain |
| Novartis Investigative Site | Alicante | 03010 | Spain |
| Novartis Investigative Site | Badalona | 08916 | Spain |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Elche | 03202 | Spain |
| Novartis Investigative Site | Girona | 17007 | Spain |
| Novartis Investigative Site | Jaén | 23007 | Spain |
| Novartis Investigative Site | Lugo | 27003 | Spain |
| Novartis Investigative Site | Madrid | 28007 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Majadahonda (Madrid) | 28222 | Spain |
| Novartis Investigative Site | Pozuelo de Alarcon (Madrid) | 28223 | Spain |
| Novartis Investigative Site | Seville | 41013 | Spain |
| Novartis Investigative Site | Valencia | 46009 | Spain |
| Novartis Investigative Site | Changhua | 500 | Taiwan |
| Novartis Investigative Site | Taichung | 404 | Taiwan |
| Novartis Investigative Site | Tainan County | 736 | Taiwan |
| Novartis Investigative Site | Taipei | 100 | Taiwan |
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| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Dnipro | 49102 | Ukraine |
| Novartis Investigative Site | Dnipropetrovsk | 49100 | Ukraine |
| Novartis Investigative Site | Lviv | 79031 | Ukraine |
| Novartis Investigative Site | Sumy | 40005 | Ukraine |
| Novartis Investigative Site | Bournemouth | BH7 7DW | United Kingdom |
| Novartis Investigative Site | Brighton | BN2 5BE | United Kingdom |
| Novartis Investigative Site | Chelmsford | CM1 7ET | United Kingdom |
| Novartis Investigative Site | Cheltenham | GL53 7AN | United Kingdom |
| Novartis Investigative Site | Colchester | CO3 3NB | United Kingdom |
| Novartis Investigative Site | Cottingham, Hull | HU16 5JQ | United Kingdom |
| Novartis Investigative Site | Derby | DE22 3NE | United Kingdom |
| Novartis Investigative Site | Edmonton | N18 1QX | United Kingdom |
| Novartis Investigative Site | Guildford | GU2 7XX | United Kingdom |
| Novartis Investigative Site | Harrogate | HG2 7SX | United Kingdom |
| Novartis Investigative Site | Huddersfield | HD3 3EA | United Kingdom |
| Novartis Investigative Site | London | SW3 6JJ | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Novartis Investigative Site | Norwich | NR4 7UY | United Kingdom |
| Novartis Investigative Site | Nottingham | NG5 1PB | United Kingdom |
| Novartis Investigative Site | Oxford | OX3 7LJ | United Kingdom |
| Novartis Investigative Site | Poole, Dorset | BH15 2JB | United Kingdom |
| Novartis Investigative Site | Sheffield | S10 2SJ | United Kingdom |
| Novartis Investigative Site | Shrewsbury | SY3 8XQ | United Kingdom |
| Novartis Investigative Site | Sutton | SM2 5PT | United Kingdom |
| Novartis Investigative Site | Whitchurch, Cardiff | CF14 2TL | United Kingdom |
| Novartis Investigative Site | York | YO31 8HE | United Kingdom |
| Result |
| Ho D, Huang J, Chapman JW, Leitzel K, Ali SM, Shepherd L, Parulekar WR, Ellis CE, Crescnzo RJ, Zhu L, Virk S, Nomikos D, Aparicio S, Gelmon KA, Carney WP, Lipton A. Impact of serum HER2, TIMP-1, and CAIX on outcome for HER2+ metastatic breast cancer patients: CCTG MA.31 (lapatinib vs. trastuzumab). Breast Cancer Res Treat. 2017 Aug;164(3):571-580. doi: 10.1007/s10549-017-4273-x. Epub 2017 May 8. |
| 28750133 | Result | Liu S, Chen B, Burugu S, Leung S, Gao D, Virk S, Kos Z, Parulekar WR, Shepherd L, Gelmon KA, Nielsen TO. Role of Cytotoxic Tumor-Infiltrating Lymphocytes in Predicting Outcomes in Metastatic HER2-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2017 Nov 9;3(11):e172085. doi: 10.1001/jamaoncol.2017.2085. Epub 2017 Nov 9. |
| FG001 |
| 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. |
|
| Randomized Not Treated |
|
| Crossed Over to Ttax/T After IA Results |
|
| Central HER2 Positive | Subset of IIT population with centrally-confirmed human epidermal growth factor receptor 2 (HER2) positive tumors. |
|
| Safety Population | All randomized subjects who receive at least one dose of investigational product |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | Participants |
| ||||||||||||||||||
| Number of Participants with the Indicated Eastern Cooperative Oncology Group Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status classifies participants according to their functional impairment, and scores indicate: 0, fully active; 1, ambulatory, restricted strenuous activity; 2, ambulatory, no work activity; 3, partially confined to bed; 4, totally confined in bed; 5, death. | Count of Participants | Participants |
| |||||||||||||||||
| Disease Status | Count of Participants | Participants |
| ||||||||||||||||||
| Central review human epidermal growth factor receptor 2 (HER2) status | Count of Participants | Participants |
| ||||||||||||||||||
| Central review estrogen receptor (ER) status | Count of Participants | Participants |
| ||||||||||||||||||
| Central review progesterone receptor (PgR) status | Count of Participants | Participants |
| ||||||||||||||||||
| Central Review of Antigen KI-67 (ki67) | Geometric Mean | Full Range | % cells positive |
| |||||||||||||||||
| Central Review of Cytokeratin 5 (CK5) Status | Count of Participants | Participants |
| ||||||||||||||||||
| Central Review of epidermal growth factor receptor (EGFR) Status | Count of Participants | Participants |
| ||||||||||||||||||
| Prior (neo)adjuvant HER2 targeted therapy | Count of Participants | Participants |
| ||||||||||||||||||
| Prior (neo)adjuvant taxane chemotherapy | Count of Participants | Participants |
| ||||||||||||||||||
| Planned taxane treatment | Count of Participants | Participants |
| ||||||||||||||||||
| Liver metastasis | Count of Participants | Participants |
| ||||||||||||||||||
| Prior neoadjuvant therapy/Other chemotherapy | Count of Participants | Participants |
| ||||||||||||||||||
| Prior neoadjuvant therapy/Anthracyclines | Count of Participants | Participants |
| ||||||||||||||||||
| Prior neoadjuvant therapy/Other therapy | Count of Participants | Participants |
| ||||||||||||||||||
| Prior neoadjuvant/Metastatic radiotherapy | Count of Participants | Participants |
| ||||||||||||||||||
| Prior neoadjuvant/Metastatic endocrine therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-Treat (ITT) and centrally-confirmed HER2 positive populations | Posted | Median | Full Range | Months | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Intent-to-Treat (ITT) and centrally-confirmed HER2 positive populations | Posted | Median | Full Range | Months | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months |
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| 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. | Intent-to-Treat (ITT) population | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of death from any cause, assessed up approximately 165 months |
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| 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. | Centrally-confirmed HER2 positive population. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of death from any cause, assessed up approximately 165 months |
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| 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. | Participants in the Intent-to-Treat (ITT) population with available data for the outcome measure. | Posted | Count of Participants | Participants | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
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| 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. | Participants in the centrally-confirmed HER2 positive population with available data for the outcome measure. | Posted | Count of Participants | Participants | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
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| 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. | Participants in the Intent-to-Treat (ITT) population with available data for the outcome measure. | Posted | Median | Full Range | Months | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
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| 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. | Participants in the centrally-confirmed HER2 positive population with available data for the outcome measure. | Posted | Median | Full Range | Months | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months |
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| 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:
| Intent-to-Treat (ITT) population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months |
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| 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:
| Centrally-confirmed HER2 positive population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months |
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| 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. | Intent-to-Treat (ITT) population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months |
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| 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. | Centrally-confirmed HER2 positive population | Posted | Number | 95% Confidence Interval | Percentage of Participants | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months |
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| 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. | Intent-to-Treat (ITT) Population. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of first response, assessed up approximately 45 months |
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| 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. | Centrally-confirmed HER2 positive population. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months |
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| 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. | 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) | Posted | Median | 95% Confidence Interval | Months | 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 |
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| 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. | 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) | Posted | Median | 95% Confidence Interval | Months | 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 |
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| 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. | Participants in the safety population with available data for the outcome measure. | Posted | Mean | Standard Deviation | Score on global scale | Week 12 |
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| 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). | 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. | Posted | Count of Participants | Participants | Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144 |
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| 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 120, Week 144 |
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| 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. | Safety Set - Canadian and Australian centers only | Posted | Count of Participants | Participants | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
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| Secondary | Number of Participant Hospitalized (Canadian and Australian Centers Only) | The number of hospitalizations were categorized: >0 and =<2, >2 and =<4 and >4. | Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit | Posted | Count of Participants | Participants | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
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| 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. | Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit | Posted | Mean | Standard Deviation | Days | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
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| Secondary | Reasons for Hospitalization (Canadian and Australian Centers Only) | The reasons for hospitalization were categorized: Breast Cancer, Febrile Neutropenia, Infection, Other and Pneumonia. | Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit | Posted | Count of Participants | Participants | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit | Posted | Count of Participants | Participants | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Discharge Destinations (Canadian and Australian Centers Only) | The discharge destinations were categorized: died, home, rehabilitation facility and transfer to other hospital. | Safety Set - Canadian and Australian centers only and for participants with Hospitalization/Inpatient visit | Posted | Count of Participants | Participants | From date of randomization till 28 days safety follow-up, assessed up to 40 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Intent-to-Treat (ITT) population. | Posted | Number | Percentage of Participants | Up to approximately 39 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Intent-to-Treat (ITT) Population. | Posted | Count of Participants | Participants | Pre-treatment deaths: Up to 1 month prior to treatment. On-treatment deaths: Up to 165 months. Post-treatment deaths: up to 166 months. |
|
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 28 days post-treat follow-up, assessed up to approximately 165 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 166 months.
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lapatinib (LTax/L) - All Participants | Lapatinib (LTax/L) - All participants: Events up to 28 days post-treatment | 21 | 326 | 106 | 322 | 316 | 322 |
| EG001 | Trastuzumab (TTax/T) | Trastuzumab (TTax/T): Events up to 28 days post-treatment | 13 | 326 | 66 | 325 | 319 | 325 |
| EG002 | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results | Lapatinib (LTax/L) - Crossed over to Trastuzumab (TTax/T) after IA results: Events up to 28 days post-treatment | 0 | 5 | 2 | 5 | 1 | 5 |
| EG003 | Lapatinib (LTax/L) - All Participants (Post-treatment) | Lapatinib (LTax/L) - All participants (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events. | 82 | 301 | 0 | 0 | 0 | 0 |
| EG004 | Trastuzumab (TTax/T) (Post-treatment) | Trastuzumab (TTax/T) (Post-treatment): Deaths in the post-treatment survival follow-up were not considered adverse events. | 73 | 312 | 0 | 0 | 0 | 0 |
| EG005 | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results (Post-treatment) | Lapatinib (LTax/L) - Crossed over to Trastuzumab (TTax/T) after IA results: Deaths in the post-treatment survival follow-up were not considered adverse events. | 0 | 5 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Platelet disorder | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sudden death | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypercalcaemia | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fistula of small intestine | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Large intestine infection | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Device related infection | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Febrile neutropenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper aerodigestive tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Injection site reaction | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Large intestine perforation | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood bilirubin | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoglobin | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lipase | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Neutrophil count | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chills | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Soft tissue infection | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Confusional state | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Multifocal motor neuropathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscular weakness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Kidney infection | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Skin infection | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastric haemorrhage | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Uterine haemorrhage | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Taste disorder | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chills | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Multifocal motor neuropathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vision blurred | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphonia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Skin infection | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Epistaxis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 1-862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| D000077341 | Lapatinib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Taiwan |
|
| Thailand |
|
| Spain |
|
| Ukraine |
|
| Russian Federation |
|
| Israel |
|
| United Kingdom |
|
| Italy |
|
| India |
|
| France |
|
| Mexico |
|
| Canada |
|
| Argentina |
|
| Poland |
|
| Belgium |
|
| Australia |
|
| Netherlands |
|
| Germany |
|
| Japan |
|
| Korea, Republic of |
|
| 1, ambulatory, restricted strenuous activity |
|
| 2, ambulatory, no work activity |
|
| Progression after therapy |
|
| Missing |
|
| Equivocal Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH) |
|
| Negative Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH) |
|
| Unknown |
|
| Negative |
|
| Missing |
|
| Negative |
|
| Missing |
|
| Negative |
|
| Missing |
|
| Negative |
|
| Missing |
|
| No |
|
| No |
|
| 3-weekly docetaxel |
|
| No |
|
| No |
|
| No |
|
| No |
|
| Missing |
|
| No |
|
| Missing |
|
| No |
|
| Missing |
|
| centrally-confirmed HER2 positive population |
|
|
| Log Rank |
| 0.0002 |
| Hazard Ratio (HR) |
| 1.484 |
| 2-Sided |
| 95 |
| 1.204 |
| 1.829 |
| Other |
|
|
|
|
|
|
|
|
|
| Crossed Over to Trastuzumab (TTax/T) After IA Results |
Crossed over to Trastuzumab (TTax/T) after IA results |
| OG003 | Overall TTax/T | Overall TTax/T |
|
|
| OG002 |
| Crossed Over to Trastuzumab (TTax/T) After IA Results |
Crossed over to Trastuzumab (TTax/T) after IA results |
| OG003 | Overall TTax/T | Overall 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.
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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.
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| OG002 | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results | Lapatinib (LTax/L) - Crossed over to Trastuzumab (TTax/T) after IA results: Participants initially randomized to Lapatinib (LTax/L) who crossed over to Trastuzumab (TTax/T) after Interim Analysis (IA) results |
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