A Phase II Study of Radiation Therapy with Pembrolizumab Immunotherapy and Olaparib in Women with Triple-Negative Breast Cancer

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Full Title

A Phase II Study of Pembrolizumab and Ablative Radiotherapy with or without Olaparib in Metastatic Triple-Negative Breast CancerS : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and Immunotherapy for the Augmentation of Immune Responses

Purpose

Radiation therapy is one of the usual approaches to treating triple-negative breast cancer (TNBC). Researchers think that adding the immunotherapy drug pembrolizumab, with or without olaparib, to radiation therapy may be a better treatment for TNBC than radiation therapy alone.

Radiation therapy alone or with olaparib may enhance the ability of the immune system to recognize and destroy TNBC cells, especially when combined with pembrolizumab. 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 women with advanced TNBC. Patients will be randomly assigned to receive radiation therapy and pembrolizumab with or without olaparib.

Pembrolizumab boosts the power of the immune system to find and kill cancer cells; its use for breast cancer is investigational. Olaparib is used to treat TNBC; its use with pembrolizumab is investigational. Olaparib is taken orally (by mouth) and pembrolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or metastatic TNBC that has not been treated with more than two prior regimens of therapy.
  • At least 4 weeks must pass since the completion of prior anticancer drugs and 2 weeks since radiation therapy and receipt of the study treatment. Patients may not have received prior PARP inhibitor treatment (the class of drugs to which olaparib belongs).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Atif Khan at 848-225-6334.

Protocol

20-505

Phase

II

Disease Status

Relapsed or Refractory

Investigator