Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.

Inclusion Criteria

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 < 10% and PR < 10% by IHC and
HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative

- Must be able to begin chemotherapy no later than day 49 after the initial surgery

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:

Inclusion criteria:

- Female

- Pre- or postmenopausal

- ECOG performance status 0-1

- Peripheral neuropathy ≤ grade 1

- Neutrophil count ≥ 2,000/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin > 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