A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)

This study tests a new treatment approach for people with early-stage triple negative breast cancer whose tumors have a high number of immune cells, called tumor-infiltrating lymphocytes or TILs, as seen by a pathologist on tissue review. A high TIL count is a sign the cancer may respond especially well to chemotherapy and immunotherapy together, meaning more toxic treatment may not be needed for everyone. All patients with high TILs will receive 12 weeks of chemotherapy (carboplatin and paclitaxel) with the immunotherapy drug pembrolizumab before surgery, without anthracyclines, a class of c

Trial Details

NCT ID

NCT07743190

Phase

PHASE2

Sponsor

Medical University of South Carolina

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Carboplatin
Paclitaxcel
Pembrolizumab

Locations (sample)

Syracuse, New York, United States|43.04812,-76.14742
Charleston, South Carolina, United States|32.77632,-79.93275

Key Eligibility Criteria

Pre-Screening Phase:
Age ≥ 18 years at the time of informed consent.
Ability to understand and willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomi…

For full eligibility, visit ClinicalTrials.gov.

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