Study Details

Open

Stereotactic radiosurgery with DDR inhibitor (Olaparib) followed by adjuvant durvalumab and chemothe

The purpose of this research study is to find out the highest dose of olaparib that is safe to give concurrently (at the same time) with stereotactic radiosurgery. Another purpose is to see if adding the olaparib concurrently with SRS followed by durvalumab and chemotherapy will lead to keeping your cancer away better than the standard approach. Olaparib is FDA approved for the treatment of breast, ovarian and pancreatic cancer. SRS is approved to treat cancer that has spread to the brain. Durvalumab is FDA approved for the treatment of urothelial and lung cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study involves blood collection for research purposes in addition to routine blood work, collection of stool for microbiome, HIV and Hepatitis testing, stereotactic radiosurgery with concurrent administration of Olaparib followed by adjuvant combination of Durvaluma and physician's choice.

Incentives

Study medication

Total length of participation:
You may remain on study as long as receiving benefits for being on study.

Looking for Specific Volunteers

Able to participate:

Patients with a breast cancer diagnosis
Patients whose breast cancer has spread to the brain and plan to have stereotactic radiosurgery
Patients who have normal organ function

Not eligible if:

Patients who have had prior whole brain radiation
Patients who have a history of severe brain injury
Patients who have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Patients unable to swallow oral medications

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Colette Shen
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Brain and Other Nervous System, Breast)

IRB Number

20-2970

ClinicalTrials.gov

NCT04711824