Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer
The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are: * Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial/non-response (RCB-I, II, III) to neoadjuvant immunochemotherapy? * Are there specific immune or molecular biomarkers (e.g., TILs…
Conditions studied
Triple-negative Breast Cancer (TNBC)
About this study
The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are: * Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial/non-response (RCB-I, II, III) to neoadjuvant immunochemotherapy? * Are there specific immune or molecular biomarkers (e.g., TILs, CD3/8/20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.
Interventions
- Biological: Additionnal breast biospy and blood sample — Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up.
Primary outcomes
- Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy (Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up).)
- Comparison of Immune Determinants According to Progression-Free Survival (PFS) (From baseline (pre-treatment) through 5 years of follow-up.)
- Comparison of Immune Determinants According to Overall Survival (OS) (From baseline (pre-treatment) through 5 years of follow-up)
Eligibility information
Study locations
- Centre Eugène Marquis, Rennes, 35000 France
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-09.