Title: Open label, phase II pilot study of immune checkpoint inhibition with pembrolizumab in combination with PARP inhibition with olaparib in advanced BRCA-mutated or HDR-defect breast cancers

Principal Investigator: Monica Mita, MD, of Cedars-Sinai Medical Center in Los Angeles, California

Description: Researchers are conducting a phase 2 trial to evaluate the efficacy of pembrolizumab plus olaparib in advanced breast cancer with a BRCA mutation or homology-directed repair (HDR) defect.

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Patients will receive pembrolizumab intravenously on day 1 of each 3-week cycle. They will also receive olaparib orally twice daily.

The primary outcome is overall response rate. Secondary outcome measures include progression-free survival, overall survival, clinical benefit rate, and duration of response.

To be eligible for this study, patients must be 18 years of age or older. They must have BRCA-mutated and/or HDR-defect breast cancer that progressed on or after therapy for locally advanced or metastatic disease. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Monica Mita in collaboration with Merck Sharp & Dohme LLC.


ClinicalTrials.gov. Pembrolizumab in combination with olaparib in advanced BRCA-mutated or HDR-defect breast cancer. NCT03025035. Accessed September 19, 2022.