Phase II study of bavituximab plus paclitaxel and carboplatin in locally advanced or metastatic breast cancer: Interim results.

1062 Background: Bavituximab, a chimeric IgG1 monoclonal antibody against the membrane phospholipid, phosphatidylserine complexed with β2-glycoprotein I on tumor vasculature, was tested in combination with paclitaxel and carboplatin in a multicenter, open label, phase 2 trial in adults (n=46) with locally advanced or metastatic breast cancer. Methods: Subjects received intravenous administration of weekly doses of 3 mg/kg bavituximab until disease progression and up to 6 cycles of carboplatin at a dose of AUC=2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28 day cycle for up to 6 cycles in a Simon 2-stage design. Tumor response was determined by use of the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Results: 46 Asian (India) female subjects median age 52 yrs (range 30-73 yrs) were treated. Prior treatment included surgery in 24 pts (52%), chemotherapy in 17 (37%), and radiation therapy in 12 pts (26%). Overall response rate (CR+PR) was 9/15 (60%, 95% CI, 32.3-83.7%) in the initia...