In this multicenter, randomized phase III trial, node positive early breast cancer patients
are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin
60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP
(epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary
study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free
survival (EFS).
Phase:
Phase 3
Details
Lead Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy