Therapy With Abraxane and 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) for Patients With Breast Cancer

Inclusion Criteria

• •Signed consent
• •Diagnosis made by core biopsy or incisional biopsy
• •Histologic confirmation of invasive breast cancer
• •Clinical staging as IIB (cT3N0 only), IIIA (cT3N1 or cT0-3N2), or IIIB (cT4N0-2)
• •ECOG performance 0 or 1
• •At the time of entry: \*Absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; \*platelet count must be greater than or equal to 100,000/mm3; \*hemoglobin must be greater than or equal to 10 g/dl; \*serum creatinine must be less than or equal to ULN for the lab.
• •The following criteria for evidence of adequate hepatic function must be met: \*Total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (\> ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and \*alkaline phosphatase must be \< 2.5 x ULN for the lab; and
• •\*AST must be less than or equal to 1.5 x ULN for the lab.
• •MUGA scan or echocardiogram within 3 months prior to entry if: \*age greater than or equal to 60, or \*history of hypertension, or \*plan to receive trastuzumab. For any patient who has a MUGA scan or echocardiogram performed for any reason, the baseline LVEF must be greater than or equal to LLN for the facility performing the procedure and there must be no regional wall abnormalities
• •Therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. Patients are eligible only if these medications are discontinued prior to randomization.
• •Use of any investigational agent within the month before enrollment in the study.