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

Exclusion Criteria

• •Clinically or radiologically detectable metastases (M0)
• •Bilateral breast cancer or contralateral ductal carcinoma in situ
• •Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type
• •Any tumor ≥T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)
• •HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive
• •Any clinically or radiologically suspect and non-explored damage to the contralateral breast
• •PATIENT CHARACTERISTICS:
• •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