Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.
Also, for axillary positive node patients, optimum chemotherapy regimens are still under
discussion. Some previous studies suggest that, in the subset of node-positive patients,
treatments based on sequential administration of anthracyclines and taxanes are more
efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic
index (activity/toxicity).
The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of
proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8
weekly paclitaxel administrations (100mg/m2).
The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The
investigators expect to increase this by 8% with the experimental treatment. With an alpha
error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250
patients are needed, 625 per arm.