Status: Closed
Activation Date: 2008JUL17
Closing Date: 2011DEC01
Phase: III
Description: A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer
Eligibility: Women with documented evidence of HER2/neu positive breast cancer (by local or central laboratory testing) which is metastatic, and with no prior chemotherapy and/or anti-HER2/neu targeted therapy in the metastatic setting.
Objective: Primary - Progression-Free Survival Secondary - Overall Survival - Time to CNS metastases at the time of progression - Incidence rates of CNS metastases at the time of progression - Overall objective response rate, time to response and duration of response - Clinical benefit response rate - Adverse event profile - Quality of Life (using the EORTC QLQ-C30 and a Trial Specific Checklist) - Clinical outcomes using biomarker changes in biological samples - Economic Evaluation: health utilities (using the EQ-5D questionnaire) and healthcare utilization
Participation: Open to member centres
Lay Description: This is a study for women with documented HER2/neu positive breast cancer which is metastatic and with no prior chemotherapy and/or anti-HER2/neu targeted therapy in the metastatic setting. HER2/neu status must be confirmed prior to randomization using either a local or the central laboratory [CTAG at the BCCA, Vancouver, Canada]. Eligible women will be assigned (open label) to one of two arms: ARM 1 - Taxane chemotherapy plus lapatinib; ARM 2 - Taxane chemotherapy plus trastuzumab. Taxane chemotherapy will include either q weekly paclitaxel or q 3-weekly docetaxel. The choice of taxane will be up to the treating physician and must be specified at the time of randomization. Patients on arm 1 will receive oral daily lapatinib concurrently with the chosen taxane for 24 weeks, and single-agent daily lapatinib thereafter, until PD. Patients on arm 2 will receive IV trastuzumab concurrently with the chosen taxane for 24 weeks, and single agent 3-weekly trastuzumab thereafter until PD.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BREAST | MA31 | 652 | 271 | 645 | 645 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| BREAST | MA31 | 652 | 10 | 486 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| BREAST | MA31 | 652 | 18 | 0 | 359 | 0 | 483 | 487 | 0 | 0 |