Mitoxantrone plus docetaxel vs single agent mitoxantrone in metastatic breast cancer (MBC): Results of a multicenter randomized trial

637 Background: The benefits of combination therapy vs less toxic single agent therapy for MBC have not been well defined. This prospective, randomized, multicenter phase IV trial compared mitroxantrone plus docetaxel (MDoc) versus mitroxantrone alone (M) as first-line therapy for MBC. Methods: High-risk, chemotherapy-naive, patients (pts) with MBC aged <35 years, with liver/lung/other metastases, or disease-free interval <18 months, were randomized to either M (12 mg/m2 q3w) for up to 6 cycles plus Doc (80 mg/m2 q3w) until progressive disease (PD) for up to 6 cycles, or to M (12 mg/m2 q3w) administered until complete response (plus 2 cycles), PD, or a cumulative dose of 160 mg/m2 had been reached. Second-line treatment was determined by each study center. The primary endpoint was overall survival (OS); secondary endpoints were time to progression (TTP), response, Brunner-Score and safety. Results: Between June 1997 and December 2001, 179 pts were randomized to MDoc (n=90) or M (n=89). Pts were observed u...