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

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