Canadian Cancer Trials Group - Tumour Bank
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MA31 Details
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. 

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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
Hide TMA Samples
(Core size is 0.6 mm)
Disease Site Trial Code Patients Accrued TMA Blocks Patients on TMA Blocks
BREAST MA31 652 10 486
Hide Fluid Samples
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 0 491 495 0 0