Last updated 4 months ago
TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
40 patients around the world
Available in Brazil
This is a phase II, single-arm clinical trial investigating a de-escalated neoadjuvant chemotherapy regimen for stage I and II triple-negative breast cancer (TNBC), guided by tumor-infiltrating lymphocytes (TILs) and radiologic response.
Patients with stage I TNBC (regardless of TIL levels) and stage II TNBC with TILs ≥ 50% will receive four cycles of carboplatin and a taxane. Those who achieve a complete radiologic response will proceed to surgery, while patients without a complete radiologic response will be escalated to a regimen including anthracycline and cyclophosphamide, with or without pembrolizumab.
The primary objective is to evaluate the pathological complete response rate. Secondary outcomes include the correlation between radiologic and pathologic response, event-free survival, and overall survival.
D'Or Institute for Research and Education
3Research sites
40Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically confirmed primary invasive breast carcinoma.One of the following conditions.Clinical stage T1c N0 M0 with any level of TILs.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.
- 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.
Sites
Instituto D'or de Pesquisa e Ensino - Rio de Janeiro
Recruiting
Instituto Rede D'Or de Pesquisa e Ensino - Bahia Hospital Aliança
Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
StudyDespaTIL
SponsorD'Or Institute for Research and Education
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07074106
