Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments 6 fec 100, 4 fec 100 followed by 4 taxol
Phase phase 3
Sponsor Association Européenne de Recherche en Oncologie
Collaborator Bristol-Myers Squibb
Trial identifier NCT00189644, AERO-B2000

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

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

Additional Information

Principal investigator Pascal Piedbois, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Association Européenne de Recherche en Oncologie.