1089 Background: The addition of bevacizumab (B) to paclitaxel (P) results in a significant improvement in PFS in pts with metastatic breast cancer (MBC) (Miller K, et al. New Engl J Med 2007). A randomized Phase II trial examining the efficacy and safety of adding gemcitabine (G) to the PB doublet has completed enrollment. Reported here are preliminary efficacy and safety results. Methods: This is a US, multicenter, randomized, superiority trial. Eligible pts have locally advanced or metastatic breast cancer, ECOG PS 0 or 1, and no prior cytotoxic therapy for metastatic disease. Prior adjuvant or neoadjuvant treatment with a taxane or endocrine therapy is allowed. Pts are randomized to receive P 90 mg/m2 on Days 1, 8, and 15, followed by B 10 mg/kg on Days 1 and 15 of a 28-day cycle, or the same regimen plus G 1,500 mg/m2 on Days 1 and 15. Primary endpoint is response rate according to RECIST criteria. Results: Between May 2006 and February 2008, 189 women were randomized to treatment. The table below summarizes currently available results. Grades 1–2 alopecia occurred in 28% of pts in the PB arm and in 38% of pts in the PB+G arm. One pt (2%) in the PB arm experienced a Grade 3 nosebleed. Grades 3 and 4 thrombotic events occurred respectively in 0% and 2% of pts in the PB arm, and in 3% and 2% of pts in the PB+G arm. Four pts (7%) in the PB arm and 3 pts (5%) in the PB+G arm discontinued due to treatment-related AEs. Three on-study deaths have occurred, none deemed related to study treatment. Conclusions: Study follow-up is ongoing. Full results will be available at the time of the meeting. Therapy with PB ± G is feasible and does not appear to be associated with significant bleeding or thrombotic events. As expected, the addition of G to the PB doublet appears to increase the incidence of neutropenia in pts with MBC. [Table: see text] [Table: see text]
Pre-specified interim analysis of the SAFE trial (NCT2236806): A 4-arm randomized, double-blind, controlled study evaluating the efficacy and safety of cardiotoxicity prevention in non-metastatic breast cancer patients treated with anthracyclines with or without trastuzumab