6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
This trial is active, not recruiting.
|Treatments||6 fec 100, 4 fec 100 followed by 4 taxol|
|Sponsor||Association Européenne de Recherche en Oncologie|
|Trial identifier||NCT00189644, AERO-B2000|
The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Female participants at least 18 years old.
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
|Principal investigator||Pascal Piedbois, MD|
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