Bevacizumab (Bev) combined with either capecitabine (X) or weekly paclitaxel (Pac) as first-line chemotherapy (CT) for HER2-negative, locally recurrent or metastatic breast cancer (LR/MBC): Preliminary safety data from the CECOG phase III TURANDOT trial.

1126 Background: The combination of Bev with first-line X or taxane-based therapy significantly improves progression-free survival (PFS) in LR/MBC. This phase III, randomized study is to determine the efficacy of Bev+Pac vs Bev+X in this setting. Methods: Patients with HER2-negative, chemonaive LR/MBC and ECOG PS 0–2 are eligible. Prior (neo)adjuvant CT is permitted if completed ≥6 months before randomization (≥12 months for taxane-containing therapy). Pts are randomized to Bev+X (X 1,000mg/m2 bid d1–14 + Bev 15mg/kg d1, q21d) or Bev+Pac (Pac 90mg/m2 d1, 8, 15 + Bev 10mg/kg d1,15, q28d), with treatment continued until disease progression, unacceptable toxicity or withdrawal of consent. Primary endpoint is non-inferiority in overall survival with Bev+X vs Bev+Pac and recruitment target is 560 pts. This planned interim safety analysis includes pts randomized by July 31, 2009 who are eligible for the safety analysis (ie. post-baseline safety data available). Results: 174 pts have been randomized, 167 are eli...