Study on Anthracycline-Free Chemoimmunotherapy Before Surgery for Triple Negative Breast Cancer Patients

Sponsor: Medical University of South Carolina

Sponsor score: 0

ClinicalTrials ID:NCT06845319

Provider View

This clinical trial is testing a new treatment approach for patients with triple-negative breast cancer who cannot use certain heart-risky drugs. The study uses a combination of chemotherapy and immunotherapy before surgery to see if it can effectively treat the cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with triple-negative breast cancer (TNBC) who have heart conditions that make them ineligible for certain standard treatments. The trial involves a combination of chemotherapy drugs (carboplatin and paclitaxel) and an immunotherapy drug (pembrolizumab) given before surgery. The goal is to see if this approach can effectively treat the cancer while being safe for patients with heart issues.

Description

This clinical trial is designed for patients with triple-negative breast cancer (TNBC) who have heart conditions that prevent them from using certain standard treatments. The study focuses on a combination of chemotherapy drugs (carboplatin and paclitaxel) and an immunotherapy drug (pembrolizumab) given before surgery. This approach aims to treat the cancer effectively while being safe for patients with heart issues.

The trial is particularly important for patients who are at high risk of heart problems from traditional treatments. It offers an alternative that avoids drugs known to cause heart damage. The study will also look at how well the treatment works in shrinking tumors and improving patient outcomes.

Participants will receive the treatment over 12 to 18 weeks before surgery. The study will monitor how well the cancer responds to the treatment and any side effects experienced by the patients. The goal is to find a safe and effective treatment option for TNBC patients with heart conditions.

Eligibility Criteria

Inclusion Criteria

  • Have a breast tumor larger than 1 cm, with or without lymph node involvement.
  • Be able to be monitored by a cardiologist or primary care doctor for heart health.
  • Be medically fit for surgery.
  • Be willing to follow all study procedures and sign a consent form.
  • Be 18 years or older, male or female.
  • Have confirmed Stage II or IIIA/B triple-negative breast cancer.
  • Have tumors that are hormone receptor-negative or low (less than 10% positive).
  • Have HER2-negative tumors.
  • Have not received previous treatment for this breast cancer.
  • Have a performance status score of 0-2, indicating good overall health.
  • Have adequate organ function based on specific blood tests.
  • Have no more than mild neuropathy.
  • Be willing to use effective birth control if of childbearing potential.
  • Be ineligible for anthracycline treatment due to heart risks or other medical reasons.
  • Have recent breast and axillary imaging.

Exclusion Criteria

  • Planning to participate in another study or have used an investigational drug recently.
  • Have metastatic or inflammatory breast cancer.
  • Unfit for surgery.
  • Have had other cancers in the last 5 years, except for certain skin cancers or carcinoma in situ.
  • Allergic to similar drugs as those used in the study.
  • Have not recovered from major surgery.
  • Have received a live vaccine recently.
  • Have an immune deficiency or are on immunosuppressive therapy.
  • Have an active autoimmune disease needing treatment in the past year.
  • Have had an organ transplant.
  • Have a history of severe lung inflammation.
  • Have an active infection needing treatment.
  • Have HIV or active hepatitis B or C.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Are pregnant or breastfeeding.
  • Have uncontrolled high blood pressure or heart rhythm issues.
  • Have a very low heart ejection fraction.

Locations

FACILITYZIPCITYSTATE
Medical University of South Carolina29425CharlestonSouth Carolina

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