6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Histologically proven cancer of the breast, Mastectomy or complete tumorectomy, Histologically proven homolateral, axillary lymph node involvement (at least 1 N+) Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months, Biological criteria (before the first FEC cycle): Neutrophils >1.5 109 /L Platelets >100 109/L Hemoglobin >10 g/dl Creatininemia <120 mmol/1 Bilirubinemia <1.5 Upper normal value Female patients over 18 years old Written and signed informed consent Performance Status less than or equal to 2 (WHO scale, see Annex IV) Exclusion Criteria: Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast, Bilateral breast cancer or history of contralateral breast cancer Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) Inflammatory breast cancer Distant metastasis or supraclavicular adenopathy Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol Psychiatric pathology Patient participating in another trial