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Phase 2 Study of Pembrolizumab and Radiation Therapy With or Without Olaparib in Women With Metastatic Triple-Negative or Hormone-Receptor PositiveHer2 Negative Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-17
34
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for women with metastatic triple-negative breast cancer or hormone-receptor positiveHer2 negative breast cancer. The study aims to compare these treatments to radiation therapy alone to see if they provide better outcomes. This is a phase II trial led by Memorial Sloan Kettering Cancer Center focusing on immune therapy combinations to enhance immune responses against these breast cancers. Participants will receive one of several treatment combinations based on their breast cancer subtype. Those with triple-negative breast cancer may receive pembrolizumab with radiation and olaparib, or pembrolizumab with radiation only. Participants with metastatic ER-positive breast cancer will receive pembrolizumab, stereotactic body radiation therapy SBRT, and olaparib. Pembrolizumab is given as a 30-minute IV infusion every three weeks for three doses. Olaparib is taken orally twice daily without breaks in 21-day cycles for a total of two cycles. Radiation is delivered in 8-9 Gy doses over three fractions, with some accommodations for larger tumors. During the study, participants will undergo regular assessments including radiographic measurements of tumors to evaluate treatment response at eight weeks from baseline. Researchers will monitor overall response rates, organ function through laboratory tests, and side effects. Participants must provide tumor tissue samples for testing. Safety and treatment effects will be closely observed, and follow-up continues as per protocol. The study includes women aged 18 and older with specific breast cancer subtypes and performance status criteria, ensuring careful monitoring throughout participation.
CONDITIONS
Brief Title
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
Research Team
A
Atif Khan, MD
S
Simon Powell, MD
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