SRS and Olaparaib followed by Durvalumab in Breast Cancer Brain Metastases

What is the Purpose of this Study?

If you choose to join this study, you will:
- Take olaparib twice a day for two weeks before SRS
- Get an infusion (IV) of durvalumab every 21 days in combination with chemotherapy after you finish olaparib + SRS
- Have physical exams and blood draws
- Have imaging done (MRI and CT)

Your study doctor will determine what your chemotherapy regimen should be after you complete SRS.
What is the Condition Being Studied?
Breast Cancer with Newly Diagnosed Brain Metastasis

Who Can Participate in this Study?

Adults ages 18+ who:

- Are diagnosed with breast cancer

- Have a newly diagnosed brain metastasis that can be treated with SRS

- Have not participated in a research study that uses durvalumab

- Have not received whole brain radiotherapy

- Are not pregnant

For more information about who can join this study, please contact the study team at 919-684-5301.

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to find out the highest dose of a drug called olaparib that is safe to give at

the same time as stereotactic radiosurgery (SRS). We also want to see if we can lessen the chance of having your cancer return by following the olaparib + SRS treatment with a combination of chemotherapy and a drug called durvalumab.

Study Details

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
Principal Investigator

Protocol Number
IRB:
PRO00108985

NCT:
NCT04711824
ClinicalTrials.gov
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