A Phase II Study of Pembrolizumab Immunotherapy plus Radiation Therapy in Women with Metastatic Triple-Negative Breast Cancer

Full Title

A Single Arm Phase II Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients

Purpose

Laboratory studies have suggested that combining radiation therapy with immunotherapy may boost the power of the immune system against cancer. In this study, researchers are evaluating the safety and effectiveness of combining the immunotherapy drug pembrolizumab with radiation therapy in patients with metastatic triple-negative breast cancer.

Pembrolizumab is already approved to treat melanoma and non-small cell lung cancer; its use in this study is considered investigational. It works by blocking a molecule called PD-1, which shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab 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.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • 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 women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Christopher Barker at 212-639-8168.

Protocol

16-032

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases