Breast Cancer Study of Preoperative Pembrolizumab + Radiation

Summary

This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy. Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.

Timeline

Start

2017-12-22

Primary completion

2025-02-06

Completion

2030-12-07

Publications

• Ho AY, Shiao S, Kobald SA, Chen J, Duda DG, Ly A, Bossuyt V, Cho HL, Arnold B, Knott S, Gupta GP, McAndrew P, Karlan S, Tighiouart M, Muzikansky A, Basho R, McArthur H. PEARL: A Phase Ib/II Biomarker Study of Adding Radiation Therapy to Pembrolizumab Before Neoadjuvant Chemotherapy in Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer. J Clin Oncol. 2024 Dec 20;42(36):4282-4293. doi: 10.1200/JCO.24.00003. Epub 2024 Sep 19.

Drugs

Indications