A Phase I/II Study of Olaparib and Stereotactic Radiosurgery Followed by Durvalumab and Chemotherapy in People with Breast Cancer That Has Spread to the Brain

Full Title

Phase I/II Study of Stereotactic Radiosurgery with Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician’s Choice Systemic Therapy in Subjects with Breast Cancer Brain Metastases

Purpose

People with breast cancer that has spread to the brain are typically treated with stereotactic radiosurgery (SRS) and chemotherapy. The purpose of this study to see if adding olaparib during SRS followed by durvalumab immunotherapy with standard chemotherapy is safe and effective in people with breast cancer that has spread to the brain. SRS is a very focused form of radiation therapy.

Olaparib will be given before and during SRS. Researchers will assess three different doses of olaparib to find the highest dose that can be given safely with SRS. They will also find out if olaparib and SRS followed by durvalumab and standard chemotherapy can shrink participants’ cancer or prevent it from returning. Olaparib is taken orally (by mouth) and durvalumab is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

• Participants must have breast cancer that spread to the brain.
• Patients must have triple-negative breast cancer or HER2-negative breast cancer with a BRCA mutation.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Linda C. Chen at 201-775-7447.