Study on Olaparib and Pembrolizumab for Treating Triple Negative or Hormone Receptor-Positive HER2-Negative Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05203445

Provider View

This clinical trial is testing a combination of two drugs, olaparib and pembrolizumab, to see if they can shrink tumors in people with certain types of breast cancer before surgery. The study aims to find out if this treatment can improve surgical outcomes by reducing the size of the cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effects of combining two drugs, olaparib and pembrolizumab, in treating people with Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative breast cancer. These drugs are given before surgery to see if they can shrink the cancer, potentially making surgery more effective. While the drugs may help reduce the tumor size, they can also cause side effects. Researchers want to determine if the treatment can shrink the cancer by a certain percentage compared to its current size, which may improve the outcome of surgery.

Eligibility Criteria

Inclusion Criteria

  • Must sign an informed consent form.
  • Must be able to follow the study protocol.
  • Newly diagnosed with specific types of breast cancer (TNBC or hormone receptor-positive, HER2-negative) at certain stages.
  • Must have a tumor that can be measured and is at least 1.5 cm in size.
  • Must have a genetic mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
  • Must be in good general health with a performance status of 0 or 1.
  • Must agree to undergo appropriate surgical management after treatment.
  • Must have a heart function of at least 53% as measured by specific tests.
  • Must have adequate organ function based on recent lab results.
  • Women must not be pregnant or breastfeeding and must agree to use contraception during and after the study.
  • Men must agree to use contraception during and after the study and not donate sperm.

Exclusion Criteria

  • Previous history of invasive breast cancer.
  • Stage IV (metastatic) breast cancer.
  • Previous systemic therapy for breast cancer.
  • Cannot have MRI scans or are allergic to certain contrast agents.
  • Previous treatment with specific immune therapies.
  • Recent systemic anti-cancer therapy or investigational agents.
  • Recent radiotherapy with unresolved side effects.
  • Recent live vaccination.
  • Immunodeficiency or recent use of high-dose steroids.
  • Other active cancers requiring treatment in the last 3 years.
  • Severe allergies to study drugs.
  • Active autoimmune diseases requiring treatment in the last 2 years.
  • History of severe lung inflammation.
  • Recent severe infections or antibiotic treatment.
  • Known history of HIV, Hepatitis B, or active Hepatitis C.
  • Active tuberculosis.
  • Any condition that could interfere with the study.
  • Psychiatric or substance abuse disorders affecting participation.
  • Pregnant or breastfeeding women, or those planning to conceive.
  • Positive pregnancy test before starting the study.
  • Recent fertility treatments affecting pregnancy test results.

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