Study on Boosting Immunotherapy Response in High-Risk Triple Negative Breast Cancer with Radiation and Myeloid Inhibition

Sponsor: Stephen Shiao

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05491226

Provider View

This clinical trial is exploring a new treatment approach for patients with high-risk triple negative breast cancer (TNBC) by combining immunotherapy with radiation and a drug that inhibits certain immune cells. The main goal is to see if this combination can eliminate cancer in the breast and lymph nodes before standard treatment. The study will also look at changes in immune cells within the tumor, safety, and survival outcomes.

Patient Parameters

Program Overview

This study is testing a new treatment for high-risk triple negative breast cancer (TNBC) that combines the immunotherapy drug pembrolizumab with radiation therapy and a drug that targets specific immune cells. The main aim is to see if this combination can completely remove cancer from the breast and lymph nodes before the usual treatment. Researchers will also check how the treatment affects immune cells in the tumor, its safety, and how long patients live without the cancer coming back.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk triple negative breast cancer (TNBC).
  • Low immune cell score in the tumor, or cancer has spread to lymph nodes, or low scores on specific cancer markers.
  • Must provide written consent and be able to follow study requirements, including blood tests and using stored tissue samples.
  • Female, 18 years or older.
  • Confirmed TNBC diagnosis through lab tests.
  • Willing to provide a new tissue sample if no stored sample is available.
  • Good overall health with a performance status of 0 or 1.
  • Must have good organ function.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control during the study.

Exclusion Criteria

  • Cancer has spread to other parts of the body.
  • Received radiation therapy within 2 weeks before starting the study.
  • Currently in another study or received experimental treatment within 4 weeks before starting the study.
  • Have an immune deficiency or are taking immune-suppressing drugs within 7 days before starting the study.
  • History of active tuberculosis (TB).
  • Allergic to pembrolizumab or its ingredients.
  • Received certain cancer treatments within 4 weeks before starting the study and not fully recovered from side effects.
  • Have another cancer that needed treatment in the last 5 years, except for certain skin or cervical cancers.
  • Active brain cancer or cancer in the brain lining.
  • Active autoimmune disease needing treatment in the past 2 years.
  • History of lung inflammation needing steroids.
  • Active infection needing treatment.
  • Any condition that might interfere with the study or is not in the patient's best interest.
  • Mental health or substance abuse issues affecting study participation.
  • Pregnant or breastfeeding, or planning to become pregnant during the study.
  • History of HIV or active hepatitis B or C.
  • Received a live vaccine within 30 days before starting the study.
  • Had an organ transplant.

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