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

DISEASE CHARACTERISTICS:

Inclusion criteria

• Histologically proven invasive unilateral breast cancer (regardless of the type)
• Initial clinical condition compatible with complete initial resection
• No residual macro or microscopic tumor after surgical excision
• Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :
• Stage II or III disease
• pT >20 mm (T1-4)
• Patients must meet 1 of the following hormone-receptor criteria:
• Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)
• Node-negative patients: triple-negative* tumor only
• NOTE: *Hormone-receptor negativity is defined as ER 9 g/dL
• AST and ALT ≤1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤2.5 times ULN
• Total bilirubin ≤1.0 times ULN
• Serum creatinine ≤1.5 times ULN
• LVEF ≥50% by MUGA scan or echocardiography
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment

Exclusion criteria

• Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer
• Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study
• Clinically significant cardiovascular disease within the past 6 months including any of the following:
• Unstable angina
• Congestive heart failure
• Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)
• Myocardial infarction
• Cerebral vascular accidents
• Known prior severe hypersensitivity reactions to agents containing Cremophor EL
• Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Patients deprived of liberty or placed under the authority of a tutor

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered
• At least 3 weeks since prior major surgery and adequately recovered
• No prior chemotherapy, hormonal therapy, or radiotherapy
• More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:
• Amiodarone
• Clarithromycin
• Amprenavir
• Delavirdine
• Voriconazole
• Erythromycin
• Fluconazole
• Itraconazole
• Ketoconazole
• Indinavir
• Nelfinavir
• Ritonavir
• Saquinavir
• No concurrent participation in another therapeutic trial involving an experimental drug