Weekly paclitaxel and capecitabine in HER2-negative metastatic breast cancer (MBC): A multicenter GINECO randomized phase II comparing two paclitaxel-capecitabine schedules

1114 Background: Paclitaxel (Ta) and capecitabine (Xel) are synergistic in vitro. Compared to a continuous weekly Tax combined with a classical 14 days (d)/21 Xel administration (Elza-Brown et al., ASCO 2000), we have explored the combination of Xel 5d/week (wk) and weekly Ta 3 wk out 4 in the objective to increase the efficacy/toxicity ratio of the TaXel combination. Methods: Patients (pts) in first or second-line of MBC, previously treated with anthracyclins + docetaxel were randomized either to A: Ta (60 mg/m2/w) + Xel (2000 mg/m2/d x 14 d/21) or to B: Ta (80 mg/m2/w) + Xel (2000 mg/m2/d x 5 d/wk) 3wk out 4. Results: From January 2006 to January 2008, 130 pts were accrued (A 66, B 64). Pts characteristics were well balanced between the two arms including median age (58 yrs), histologic type and grade, hormone receptor-positive tumor (80%), previous treatment, visceral disease (72%), number of sites (>1; 63%), ECOG PS (0; 42%, 1; 58%). Pts received a median of 6 cycles (1–23) with a received/planned mea...