Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additionnal breast biospy and blood sample.
- Who it may be relevant to
- Registry conditions: Triple-negative Breast Cancer (TNBC). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 outcome measures
- Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy [Time frame: 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) [Time frame: From baseline (pre-treatment) through 5 years of follow-up.]
- Comparison of Immune Determinants According to Overall Survival (OS) [Time frame: From baseline (pre-treatment) through 5 years of follow-up]
Eligibility criteria
Inclusion criteria
- Female.
- Age ≥ 18 years.
- Histologically confirmed invasive triple-negative breast cancer (ER and PR < 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III.
- Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen.
Indication for intra-tumoral clip placement.
\- Signed written informed consent
Exclusion criteria
- Pregnant or breastfeeding women.
- Hematoma requiring Grade II analgesics after diagnostic biopsy.
- Known coagulation disorders.
- Adults under guardianship, curatorship, or legal protection, or deprived of liberty.
- Not affiliated with a social security system.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Eugène Marquis — Rennes
Identifiers
NCT: NCT07570524 · 2025-4-83-004