A Phase III Study of Pembrolizumab Immunotherapy versus Single-Agent Chemotherapy to Treat Metastatic Triple-Negative Breast Cancer

Full Title

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) (KEYNOTE-119)

Purpose

The purpose of this study is to compare the drug pembrolizumab with standard treatment using another chemotherapy drug for patients with metastatic triple-negative breast cancer (cancers which don't express estrogen receptors, progesterone receptors, or HER2).

Pembrolizumab is already approved to treat melanoma and non-small cell lung cancer. It is a form of immunotherapy that works by blocking a molecule called PD-1, which suppresses immune responses. Blocking PD-1 can allow for a more robust immune response to cancer cells. Pembrolizumab is given intravenously (by vein).

Patients in this study will be randomly assigned to receive pembrolizumab or standard-of-care chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine).

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 continues to grow despite one or two prior regimens of therapy.
  • Patients must recover from the serious side effects of previous treatments before entering the study.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Elizabeth Comen at 646-888-4525.

Protocol

16-077

Phase

III

Investigator

Co-Investigators

Diseases