Status: Closed
Activation Date: 2002FEB07
Closing Date: 2004APR05
Phase: III
Description: A Randomized Three-Arm Multi-Centre Comparison of 1 Year and 2 Years of Herceptin versus no Herceptin in Women With HER2-positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Eligibility: Women with primary breast cancer that over-expresses HER2 (determined by IHC 3+ or FISH positive) who have completed (neo-) adjuvant systemic chemotherapy and radiotherapy, if applicable.
Objective: To compare disease-free survival (DFS) in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin? for one year versus no Herceptin?. To compare DFS in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin? for two years versus no Herceptin?.
Participation: Open to member centres
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
BREAST | MA24 | 160 | 6 | 0 | 6 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
BREAST | MA24 | 160 | 0 | 0 |
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 | MA24 | 160 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |