A Phase I Study of Whole Brain Radiation Therapy plus Sorafenib for Patients with Breast Cancer Brain Metastases

Protocol
12-046
Full Title
Whole Brain Radiotherapy (WBRT) with Sorafenib for Breast Cancer Brain Metastases (BCBM): A Phase I Study
Phase
I
Purpose

Sorafenib is an anticancer drug approved for the treatment of liver and kidney cancers. It works by targeting proteins involved in cancer growth and by inhibiting the development of the blood vessels that tumors need to grow and spread. In laboratory studies and in some patients, it has been studied for the treatment of tumors in the brain.

In this study, researchers want to find the highest dose of sorafenib that can be given safely with whole brain radiation therapy in patients with breast cancer that has metastasized to the brain. Investigators will also observe the preliminary effectiveness of the combination of sorafenib and whole brain radiation for treating these patients.

Some patients may be asked to concurrently participate in protocol 12-039 (a PET imaging protocol).

Eligibility

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

  • Patients must have brain metastases from breast cancer. Those with leptomeningeal metastases may not participate.
  • Patients may have had any number of prior therapies, but therapy must have been completed at least 2 weeks before entering the study. Patients who are taking trastuzumab (Herceptin) may continue to take it.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrew Seidman at 646-888-4559.

Disease(s)
Brain Tumors, Metastatic
Breast Cancer