Study on Palliative Radiation and Pembrolizumab for Unresectable Metastatic Stage IV Breast Cancer

Sponsor: University of Louisville

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04990921

Provider View

This clinical trial is testing the combination of a specific type of radiation therapy and the drug pembrolizumab to see if it can help control breast cancer that cannot be surgically removed and has spread to other parts of the body after previous treatments.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of combining stereotactic body radiation therapy (SBRT) with pembrolizumab for patients with stage IV breast cancer that cannot be removed by surgery and has spread to other areas. This trial is for patients whose cancer has progressed after two previous treatments.

Description

This study is for women over 18 years old with a confirmed diagnosis of stage IV breast cancer that cannot be surgically removed or has spread to other parts of the body. Participants must have measurable cancer and be suitable for a type of radiation therapy called stereotactic body radiation therapy (SBRT). They should have a good overall health status and have already tried two different treatments approved by the FDA.

For patients with triple-negative breast cancer, they must have previously received taxane therapy. Those with ER+ breast cancer should have had a CDK 4/6 inhibitor treatment. Patients with Her2 overexpressed cancer should have been treated with trastuzumab and ado-trastuzumab (TDM-1).

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Confirmed diagnosis of breast cancer that is stage IV and cannot be surgically removed.
  • Suitable for palliative SBRT.
  • Have at least one measurable cancer lesion.
  • Have recovered from any major surgery before joining the study.
  • Have tried two previous treatments, including taxane therapy for certain types of breast cancer.
  • Have adequate organ function based on specific blood tests.
  • Not pregnant and willing to use contraception if of childbearing potential.
  • ECOG performance status of 0, 1, or 2.

Exclusion Criteria

  • More than 4 active brain metastases.
  • Any other significant health condition that could interfere with the study.
  • Active autoimmune disease that could worsen with pembrolizumab.
  • Significant immunosuppression or infection.
  • Known allergies to study drugs.
  • HIV, hepatitis B, or hepatitis C infection.
  • Recent stem cell transplant.
  • History of tuberculosis or pneumonitis.
  • Not suitable for palliative SBRT.
  • Recent participation in another clinical trial.
  • Pregnant or breastfeeding women.
  • Not willing to use contraception if of childbearing potential.
  • Unlikely to complete all study visits or procedures.

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