Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

Recruiting now

Conditions studied: Triple-negative Breast Cancer (TNBC)

In brief

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.

Key facts

Study ID

NCT07570524

Run by

Center Eugene Marquis

People needed

200

Starts

2026-06-25

Expected to finish

2036-06-25

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Centre Eugène Marquis — Rennes, France (enrolling)

Full record on ClinicalTrials.gov

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