Triple-negative breast cancers do not express the HER2 protein nor contain estrogen or progesterone receptors. The purpose of this study is to see if treatment with the investigational drug tivozanib plus the standard anticancer drug paclitaxel is more effective than paclitaxel alone in women with triple-negative breast cancer that has persisted or returned despite prior therapy.
Tivozanib works by inhibiting the development of the blood vessels that tumors need to grow and spread. It is taken orally (by mouth). Patients will be randomly assigned to receive paclitaxel (which is given by vein) with tivozanib or a placebo (sugar pill).