Neoadjuvant chemotherapy for large operable (LO) or locally advanced (LA) breast cancer (BC) has been shown to increase the rate of conserving breast surgery, without compromising overall survival. However, the optimal regimen remains unknown. Previous studies using infusional 5-FU (5-FU-infu) in association with epirubicin and cisplatin/carboplatin (ECisF) for LO and/or LABC have shown high response rates and good tolerability. The dose of epirubicin used in those studies was 50 mg/m2, q3w. As there is a well-known dose-response effect for anthracyclines, the aim of this study was to identify the maximum tolerated dose of epirubicin, when given in association with the other two drugs.