NCT03025035

Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Yuan Yuan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.

Detailed description

There are two BRCA genes, BRCA1 and BRCA2, and they play a role in protecting cells from cancer. HDR-defect is another type of gene mutation that can contribute to development and progression of cancer. If one of these genes is mutated, cells may rapidly change and divide, which can lead to cancer. Pembrolizumab is a drug that works with the immune system to target the tumor (immunotherapy). The investigators want to know if combining pembrolizumab and Olaparib therapy will be able to reduce the size and amount of cancer cells with fewer side effects than standard treatment by targeting the tumor. This research study is designed to test the investigational use of pembrolizumab and Olaparib in breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab IV solution administered on Day 1 of each 3-week cycle
DRUG	Olaparib	Olaparib administered orally twice a day

Timeline

• Start date: 2017-09-10
• Primary completion: 2024-10-08
• Completion: 2025-11-21
• First posted: 2017-01-19
• Last updated: 2026-02-06
• Results posted: 2025-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study