TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC

This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment. Patients with stage I triple-negative breast cancer (regardless of TIL levels) and those with stage II disease and high TILs (50% or more) will receive a combination of two chemotherapy drugs (carboplatin and a taxane) for four cycles. If imaging shows the tumor has completely disappeared after this treatment, the patient will go straight to surgery. If the tumor is still visible, the treatment will be strengthened with additional chemotherapy drugs (anthracycline and cyclophosphamide), with or without a medicine called pembrolizumab, which helps the immune system fight cancer. The main goal of the study is to see how many patients have a complete disappearance of the cancer after treatment. Other goals include understanding how imaging results relate to what is found during surgery and tracking how long patients live without the cancer coming back.

NCT Number	NCT07074106
Lead Sponsor	D'Or Institute for Research and Education Collaborators: Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
Conditions	Breast Cancer
Enrollment	40 participants
Start Date	2025-10-31
Primary Completion	2027-07-01 (estimated)
Study Completion	2028-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-01