Toxicity results and early outcome data on a randomized phase II study of docetaxel {+/-} bevacizumab for locally advanced, unresectable breast cancer

3049 Background: Preclinical models of combination angiogenesis inhibitor bevacizumab (rhuMAbVEGF) and docetaxel demonstrate synergistic suppression of capillary vessel formation. Based upon these data, we developed a randomized phase II trial in order to evaluate the vascular effects on tumor regression with combination bevacizumab/docetaxel vs. docetaxel in the treatment of locally advanced breast cancer. Methods: 49 patients (pts) were randomized to receive neoadjuvant therapy with bevacizumab (10 mg/kg qowk) and docetaxel (two 8-week cycles of 35 mg/m2 weekly x 6 with a 2 wk break) (BD=24) or docetaxel (D=25) alone. Eligible pts had locally unresectable breast cancer with (n=6) or without distant metastasis (n=43); 16 patients presented with inflammatory breast cancer. Pts whose disease responded, sequentially underwent definitive surgery (4 weeks after BD or D), radiation, 4 cycles of conventional Adriamycin/cyclophosphamide, and tamoxifen or anastrazole (if ER/PR+). Results: Among the 49 pts: 7 clin...