Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer

OBJECTIVES: Primary * To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer. Secondary * To compare the 5-year distant metastasis-free survival. * To compare the 5-year event-free survival. * To compare the 5-year overall survival. * To compare the safety profiles for the two chemotherapy regimens. * To identify and/or validate predictive-gene expression profiles of clinical response/resistance to the two treatment regimens. * To bank frozen and fixed tumor and frozen serum prospectively for future translational studies in both genomics and proteomics (transcriptome and proteome analyses, tissue array analyses). * To compare the cost-effectiveness of these 2 regimens. * To compare the quality-of-life of patients treated with these 2 regimens. OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs post-menopausal), and tumor hormone-receptor status (triple-negative vs progesterone-receptor negative, HER negative, and estrogen-receptor \[ER\] positive). Patients are randomized to 1 of 2 treatment arms. * Docetaxel Arm: Patients receive epirubicin hydrochloride IV, fluorouracil IV, and cyclophosphamide IV every 3 weeks in courses 1-3 and docetaxel IV alone every 3 weeks in courses 4-6. * Ixabepilone Arm: Patients receive treatment in courses 1-3 as in arm I and ixabepilone IV alone every 3 weeks in courses 4-6. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also complete a quality of life questionnaire periodically. After completion of study treatment, patients are followed periodically for up to 10 years.