Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer

OBJECTIVES: Primary * Compare the disease-free survival rate in women with stage III breast cancer treated with adjuvant chemotherapy with vs without darbepoetin alfa. Secondary * Compare local recurrence and overall survival in patients receiving these regimens. * Compare toxicity of these regimens in these patients. * Compare quality of life and fatigue frequency in patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according the chemotherapy regimen (CEF vs TAC). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive 1 of the following regimens: * Regimen CEF: Patients receive cyclophosphamide IV, epirubicin hydrochloride IV, and fluorouracil IV on day 1. * Regimen TAC: Patients receive docetaxel IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression and unacceptable toxicity. * Arm II: Patients receive 1 of the following regimens: * Regimen CEF: Patients receive regimen CEF as in arm I. Patients receive darbepoetin alfa if hemoglobin falls to ≤ 13.0 g/dL. Darbepoetin alfa is discontinued when hemoglobin rises to \> 14.0 g/dL. * Regimen TAC: Patients receive TAC as in arm I and darbepoetin alfa as in arm II, regimen CEF. Quality of life is assessed at baseline, before each chemotherapy course, at the completion of study therapy, and at 6 and 12 months. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 1,234 patients will be accrued for this study.