Status and phase
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About
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.
Sex
Ages
Volunteers
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):
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
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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