NCT05203445

A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer

Phase II of Neoadjuvant Olaparib in Combination With Pembrolizumab in Patients With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer and Germline Mutations in DNA Damage Repair Genes

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test any good and bad effects of combining the study drugs pembrolizumab and olaparib, given before the standard surgical procedure, to treat TNBC or HR+ HER2- breast cancers. The study drugs could shrink cancer, but they could also cause side effects. The study researchers want to find out whether the study drugs will shrink the cancer by a certain percentage compared with its current size, which may improve the outcome of surgery.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib 300 mg orally BID
DRUG	Pembrolizumab	Pembrolizumab 400 mg intravenously q6weeks

Timeline

• Start date: 2022-01-31
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-01-24
• Last updated: 2026-01-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study