Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer

Inclusion Criteria: * Patient with histologically proven breast cancer * Surgical resection performed with clear margins (R0 resection) * At least 1 histologically proven involved axillary node * ER + or ER- * Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days * Aged over 18 years, and more than 10-year life expectancy * ECOG performance status 0-1 * Signed informed consent form prior to randomization Exclusion Criteria: * Bilateral breast cancer * Inflammatory breast cancer * Personal history of breast cancer * Immunohistochemical only node involvement * Intraductal breast cancer * Distant metastases * Contraindication to any drug contained in the chemotherapy regimens * Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease * Poor renal function (creatinin level \> 120 micromol/L), poor hepatic function (total bilirubin level \> 1 UNL), transaminases \> 2.5 UNL) * Poor bone marrow reserve as defined by neutrophils \< 1.5 G/L or platelets \< 100 G/L; Hemoglobin \< 10 G/dL * Poor contractile cardiac function (LVEF \< 50%) * Coronary disease * Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma * Pregnancy or breast feeding * Absence of contraception in non menopausal women * Adult patient unable to give informed consent because of intellectual impairment * Concomitant participation to another trial