Predicting immunochemotherapy response in early TNBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this observational study, researchers will collect additional breast biopsies and blood samples from eligible patients to analyze immune cells and molecular signatures in the tumor and its microenvironment. They will compare immune/molecular profiles between those achieving complete pathological response (no residual disease) and those with residual disease after treatment. The goal is to identify biomarkers that correlate with progression-free and overall survival and to see if profiles can guide personalized therapy plans. The study focuses on women 18 and older with stage II–III TNBC treated with the Keynote-522 regimen. Location is Centre Eugène Marquis in Rennes, France.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Eugène Marquis
  Rennes, France Recruiting

Study contacts

• Principal investigator: Antoine DELEUZE, Dr — Centre de lutte contre le cancer Eugène Marquis
• Study coordinator: Valérie JOLAINE
• Email: v.jolaine@rennes.unicancer.fr
• Phone: 0299253036

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.