Purpose of this Study
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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Take olaparib twice a day for a week before before SRS and up to 28 days afterward
- 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)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
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
Carey
Anders
Protocol Number
PRO00108985
NCT ID
NCT04711824
Phase
I/II
Enrollment Status
Open to Enrollment