RecruitingPhase 2NCT04683679

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

Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Immunotherapy Combinations for the Augmentation of Immune Responses

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

34 participants

Start Date

Apr 21, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Triple-Negative Breast Cancer Metastatic Breast Cancer TNBC - Triple-Negative Breast Cancer

Summary

The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radiation therapy alone).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combinations of radiation therapy with pembrolizumab (an immunotherapy) and olaparib or other drugs in women with metastatic or recurrent triple-negative breast cancer (TNBC) or hormone receptor-positive, HER2-negative breast cancer. The goal is to find effective treatment combinations for these hard-to-treat cancers. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with metastatic or recurrent triple-negative breast cancer (TNBC) or ER+/HER2-negative breast cancer - You have been confirmed by biopsy or cytology - You have a good performance status (ECOG 0–1) - For TNBC: you may have had prior immunotherapy **You may NOT be eligible if...** - You do not have confirmed metastatic or recurrent disease - Your performance status is too low - You have not received prior required treatments for your specific cancer subtype Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks for 3 doses

DRUGOlaparib

Olaparib will be administered twice daily continuously without breaks on a 21-day (3 week) cycle length, for a total of 2 cycles. Olaparib tablets will be administered bid (2 x 150 mg tablets twice daily; total 600 mg daily) on continuous days without interruption for 2 cycles. Each 3 week period constitutes one cycle.

RADIATIONRadiation

The dose of radiation will be 8-9 Gy x 3 fractions. Radiation therapy will begin on C1D2-7. For tumors that are too large for this schedule, an accomodation of 30 Gy in 6 Gy per fraction is allowed, a schedule commonly used at MSK.