Study on Radiation Therapy with Pembrolizumab and Olaparib for Women with Certain Types of Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04683679

Provider View

This clinical trial is exploring whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for women with metastatic breast cancer. The study aims to determine if this combination is better, the same, or worse than radiation therapy alone.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for women with metastatic breast cancer. Researchers want to see if this new combination works better than the usual approach of using radiation therapy alone.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older with a confirmed diagnosis of triple-negative breast cancer or hormone-receptor positive/Her2 negative breast cancer.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have metastatic or recurrent triple-negative or hormone-receptor positive breast cancer.
  • For triple-negative breast cancer, must have previously received immune checkpoint inhibitors with progression or be PDL1-negative.
  • Must have measurable disease based on specific criteria, with at least one non-bone metastatic lesion that can be measured.
  • No more than 3 prior lines of systemic therapy for metastatic triple-negative breast cancer.
  • Must have at least one tumor site suitable for palliative radiation therapy.
  • Must provide a tumor tissue sample for testing.
  • Must not be pregnant or breastfeeding and agree to use contraception if of childbearing potential.
  • Must have adequate organ function based on specific laboratory tests.
  • Must agree not to breastfeed during the study and for 180 days after the last dose.
  • Must be able to swallow and retain oral medications.

Exclusion Criteria

  • More than 3 lines of systemic therapy for metastatic triple-negative breast cancer.
  • Positive pregnancy test or not using effective contraception if of childbearing potential.
  • Recent use of anti-cancer agents or participation in another clinical trial within a specified time before starting the study.
  • History of severe allergic reactions to pembrolizumab or olaparib.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Active infection requiring treatment or known history of HIV, Hepatitis B, or Hepatitis C.
  • Pregnant or breastfeeding, or planning to conceive during the study.
  • Recent major surgery or unable to swallow oral medications.
  • Use of certain medications that interact with the study drugs.
  • Any condition that might interfere with the study or is not in the best interest of the participant.

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