A Phase III Study Comparing Sacituzumab Govitecan with Standard Chemotherapy in Patients with Advanced Triple-Negative Breast Cancer

Full Title

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

Purpose

Triple-negative breast cancers do not respond to treatments that target receptors for estrogen, progesterone, or the HER2 protein, and can be challenging to treat successfully. The purpose of this study is to compare the effectiveness of the investigational drug sacituzumab govitecan with standard chemotherapy in patients with advanced triple-negative breast cancer that has continued to grow despite two prior regimens of therapy.

Sacituzumab govitecan is composed of an antibody that binds to certain receptors on breast cancer cells, where it then releases a drug that kills cancer cells. In this study, patients will be randomly assigned to receive sacituzumab govitecan or the physician’s choice of standard chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine). Sacituzumab govitecan is given intravenously (by vein).

Eligibility

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

  • Patients must have metastatic triple-negative breast cancer that has continued to grow despite two prior regimens of therapy.
  • Patients’ previous treatment must have contained a taxane drug.
  • At least 2 weeks must pass between the completion of prior treatment and entry into the study (3 weeks since any antibody therapy).
  • 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 for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-5209.

Protocol

18-064

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Vahdat, Linda, MD

Diseases