SRS and Olaparaib followed by Durvalumab in Breast Cancer with Brain Metastases (SOLARA)

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

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)
Your study doctor will determine what your chemotherapy regimen should be after you complete SRS. We are also doing a sub-study for breast cancer patients who are having their brain metastases surgically removed. If you are eligible to join the sub-study rather than the main study, you will also take olaparib for a week before your surgery but you will not get durvalumab in combination with chemotherapy afterward in the same manner as the main study. You might be able to join the main study after you finish the sub-study if you are scheduled for SRS after your surgical resection.

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
ClinicalTrials.gov