A Phase II Study of Paclitaxel plus Tivozanib or Placebo in Women with Persistent or Recurrent Triple-Negative Breast Cancer

Protocol
13-047
Full Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Multi-Center Study Comparing Tivozanib Hydrochloride In Combination With Paclitaxel Versus Placebo In Combination With Paclitaxel in the Treatment of Subjects With Locally Recurrent and/or Metastatic Triple Negative Breast Cancer
Phase
II
Purpose

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).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be women with inoperable recurrent or metastatic triple-negative breast cancer.
  • Patients may not have received systemic therapy for advanced or metastatic breast cancer.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Maura Dickler at 646-888-5456.

Disease(s)
Breast Cancer
Locations
Related Diseases