ABSTRACT
This multicenter, multigroup phase III clinical trial compared PFS and OS in locally advanced (LABC) and inflammatory (IBC) breast cancer patients randomized to two epirubicin-containing regimens, one at a conventional dose (arm A, epirubicin 60 mg/m2 d1,8 q28d 6), the other at a dose that was dense and intense (arm B, epirubicin 120 mg/m2 q14d 6). After 5.5 years median follow up, there have been 277 events among 448 randomized patients. No difference in PFS was apparent. No survival advantage was seen for CEF (34 months) or EC (33.7 months), p 0.68. Toxicity in arm B was manageable in an outpatient setting. QOL, which was reported separately [71], was inferior for arm B during the first 3 months, but by one year there were no differences.
