A Pilot Study of Radiation Therapy to the Brain plus Tremelimumab to Treat Metastatic Breast Cancer

Full Title

A Pilot Study of Brain Irradiation and Tremelimumab in Metastatic Breast Cancer

Purpose

Studies suggest that combining radiation therapy with an immunotherapy may be more effective than either treatment alone for treating cancer, including cancer that has spread to the brain. The purpose of this study is to evaluate the safety and effectiveness of giving the immunotherapy tremelimumab with radiation therapy in patients with breast cancer that has spread to the brain.

Tremelimumab blocks cytotoxic T lymphocyte antigen 4 (CTLA4), a protein found on cells of the immune system. CTLA4 puts the brakes on the immune response and may prevent immune cells from attacking cancer cells. Tremelimumab prevents this from happening, potentially enhancing the immune response against the cancer. It is approved for treating a cancer called mesothelioma; its use in this study is considered investigational.

Patients in this study will receive radiation therapy plus tremelimumab. Patients whose cancers are positive for the HER2 receptor may also receive HER2-directed therapy (such as trastuzumab) while on the study. Both tremelimumab (and trastuzumab) are 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 breast cancer that has spread to the brain and be candidates for radiation therapy.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Kathryn Beal at 212-639-5159.

Protocol

15-038

Phase

Pilot

Investigator

Co-Investigators