Randomized phase II study of capecitabine with or without ramucirumab (IMC-1121B) or IMC-18F1 in patients with unresectable, locally advanced or metastatic breast cancer (mBC) previously treated with anthracycline and taxane therapy (CP20-0903/NCT01234402).

TPS151 Background: Ramucirumab is a fully human IgG1 monoclonal antibody (MAb) that targets the VEGFR‐2, blocks the interaction of VEGF and VEGFR‐2 and neutralizes VEGF-induced mitogenesis of human endothelial cells. Treatment with DC101 (MAb targeting murine VEGFR-2) impairs vascular function and increases tumor hypoxia in the MDA-MB-231 breast cancer xenograft model (Cancer Res. 2006;66:3639-48) and inhibits tumor growth in cytotoxic therapy-resistant breast cancer xenograft models (Clin Cancer Research. 2002;8:221–32). IMC-18F1 is a fully human IgG1 MAb which targets human VEGFR-1 (Flt-1). IMC‐18F1 binds to VEGFR-1 and blocks receptor binding of VEGF-A, VEGF-B, and PlGF, and inhibits subsequent signaling. IMC-18F1 and MF1 (MAb targeting murine VEGFR-1) treatment with 5-FU/LV, cyclophosphamide, or doxorubicin resulted in enhanced antitumor efficacy compared with cytotoxic monotherapy in MD-MBA-231 tumor xenografts (Clin Cancer Res.2006;12:6573-84). Methods: This 3-arm study opened for accrual in 11/2010...