Breast Cancer Treated by Neoadjuvant Chemotherapy

Inclusion Criteria:

• Patient with histological proof of non metastatic breast cancer, whose clinical tumor diameter is > 2 cm, or < 2 cm, but situated in areolar area of the nipple.
• T2-T3, N0-N1 tumor, non-inflammatory, unilateral, non-metastatic, grade II – III, HER2-neu negative, without extension beyond the breast and axillar area.
• Performance Status = 0-1 WHO.
• Patient non pretreated for breast cancer.
• Patient without cardiac pathology and without anthracyclines contra-indication (assessed by normal ejection fraction).
• Normal haematological, renal and hepatic functions : PNN > 2.109 /l, platelets > 100. 109 /l, Hb > 10 g/dl, normal bilirubin serum , ASAT and ALAT < 2,5 ULN, alkaline phosphatases < 2,5 ULN, creatinin < 140 µmol/l or creatinin clearance > 60 ml/min
• Written informed consent dated and signed by the patient

Exclusion Criteria:

• All other breast cancers than those described in inclusion criteria, in particular inflammatory and/or neglected (T4b or T4d) forms.
• Patient presenting with plurifocal tumors, multicentric tumor, bilateral tumor.
• Grade I well differentiated tumor.
• HER2 neu 3 + (ICH or FISH or CISH) tumor.
• Non measurable lesion, in the two diameters, whatever radiological methods used.
• Patient presenting microcalcifications for which breast conservation is not possible.
• Patient already operated for breast cancer or having had primary axillar node dissection.
• Patient having antecedent of other cancer, exception for in situ uterine cervix or basocellular skin cancer, considered as healed.
• Patient presenting another pathology considered as incompatible with patient inclusion in the study
• Patient should not receive treatment with any other investigational drug and should not participate to another clinical study in a delay < 30 days or should not be pre-treated by cytostatic chemotherapy.
• Antecedents of allergy to polysorbate 80.
• Patient who is pregnant or lactating and not using effective contraceptive method.
• Any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow up schedule, assessed with the patient prior to registration in the trial