Recruiting

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

ClinicalTrials.gov IDNCT07074106

PhasePHASE2

Enrollment40

SponsorD'Or Institute for Research and Education

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Interventions

Drug: Carboplatin and a Taxane — All patients will receive Carboplatin and a Taxane for 4 cycles. * Patients who achieve a complete radiological response will proceed directly to surgery. * Patients without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery.

Primary outcomes

Pathological complete response rate after 4 cycles of Carboplatin plus Paclitaxel. (3 mo)

Eligibility information

Inclusion Criteria: * Histologically confirmed primary invasive breast carcinoma. * One of the following conditions: * Clinical stage T1c N0 M0 with any level of TILs; or * Clinical stage T2 N0 M0 with TILs ≥ 50%. * Estrogen receptor (ER) and progesterone receptor (PR) expression \< 10%. * HER2-negative or non-amplified, according to current ASCO-CAP criteria. * No evidence of distant metastasis based on imaging performed prior to study entry (chest/abdomen/pelvis CT scan or FDG PET-CT). * Age ≥ 18 years. * ECOG performance status of 0 to 2. * Adequate organ function Exclusion Criteria: * The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), active ischemic heart disease, or chronic liver or kidney disease. * Pregnant or breastfeeding participants. * History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.

Study locations

Instituto D'Or de Pesquisa e Ensino de Brasília, Brasília, Brazil
Instituto D'Or de Pesquisa e Ensino de Curitiba, Curitiba, Brazil
Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro, Rio de Janeiro, Brazil
Instituto D'Or de Pesquisa e Ensino de Salvador, Salvador, Brazil
Instituto D'Or de Pesquisa e Ensino de São Paulo, São Paulo, Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.