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Clinical Trials in Brazil / NCT07074106
Recruiting Phase 2

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

NCT07074106 · tracked via the Priya Life Science Brazil tracker
Sponsor
D'Or Institute for Research and Education
Phase
Phase 2
Started
2025-10-31
Last updated
2026-04-01

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Carboplatin and a Taxane

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Instituto D'Or de Pesquisa e Ensino de Brasília Brasília Brazil Recruiting
Instituto D'Or de Pesquisa e Ensino de Curitiba Curitiba Brazil Not Yet Recruiting
Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro Rio de Janeiro Brazil Recruiting
Instituto D'Or de Pesquisa e Ensino de Salvador Salvador Brazil Recruiting
Instituto D'Or de Pesquisa e Ensino de São Paulo São Paulo Brazil Recruiting

More D'Or Institute for Research and Education trials in Brazil

Dose Optimization and Efficacy Assessment of a Fluoropyrimidine Antidote Starting soon
Development of Polygenic Risk Scores in Colon Cancer Patients Through the Study of Ancestry and Diversity in Genetic Maps of the Brazilian Population - ORIGEM Project Enrolling by invitation
Encouraging Positive Parenting Habits Recruiting
Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemotherapy Treatment Starting soon

Other trials for the same condition

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction Recruiting
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer Active, not recruiting
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer Active, not recruiting
CRYoablation for Small Tumors As Local Treatment - SIX Trial Recruiting
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07074106 on ClinicalTrials.gov ↗ ← All trials in Brazil