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.
Eligibility
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.
