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Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

RECRUITINGSponsored by Center Eugene Marquis
Actively Recruiting
SponsorCenter Eugene Marquis
Started2026-06-25
Est. completion2036-06-25
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions3

Breast CancerCancerTriple Negative Breast Cancer (TNBC)

Interventions1

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