Status: Closed
Activation Date: 2000DEC04
Closing Date: 2005APR29
Phase: III
Description: A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer
Eligibility: Women with histologically confirmed adenocarcinoma of the breast treated with either total or partial mastectomy; node positive or high risk node negative; T0-T4, N0, N1, or N2, M0; ER status must be known; < 60 years of age; no prior chemotherapy, hormonal therapy, immunotherapy or radiotherapy for breast cancer; adequate blood counts; ECOG < 2; LVEF > institutional lower normal limit; no history of cardiac disease.
Objective: To compare disease-free survival and overall survival among the three treatment arms. To compare rate of toxicities and quality of life among the three treatment arms.
Participation: Not Limited
Lay Description: The purpose of this study is to compare the effects (on you and your breast cancer) of three different combinations of drugs which are commonly used to treat this disease. If you are randomized to Group 1 you will receive three commonly-used chemotherapy drugs called cyclophosphamide, epirubicin and 5 fluorouracil. If you are randomized to Group 2 you will receive three commonly-used chemotherapy drugs called cyclophosphamide, epirubicin and paclitaxel. If you are randomized to Group 3 you will receive three commonly-used chemotherapy drugs called doxorubicin, cyclophosphamide and paclitaxel. This research is being done because currently we do not know which of these three combinations of drugs is better than the others.
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
BREAST | MA21 | 2104 | 1203 | 1488 | 1488 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
BREAST | MA21 | 2104 | 27 | 1084 |
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 | MA21 | 2104 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 |