PATIENTS AND METHODS: Four hundred seventeen anthracycline-naive MBC patients were randomized to receive one of the following regimens: arm A: 11 cycles of fluorouracil 500 mg/m(2), epirubicin 75 mg/m(2), and cyclophosphamide 500 mg/m(2) (FEC 75) every 21 days; arm B: four cycles of FEC 100 (same regimen but with epirubicin 100 mg/m(2)) then eight cycles of FEC 50 (epirubicin 50 mg/m(2)); and arm C: four cycles of FEC 100 then restart the same regimen at disease progression in case of prior response or stabilization.