NCT07570524Recruiting
Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 25 Jun 2026
- Primary completion date
- 25 Jun 2036
- Lead sponsor
- Center Eugene Marquis
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07570524
What you commit to
- Study type: Observational
- Planned participants: 200
- From 25 Jun 2026 to the primary completion date, 25 Jun 2036
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known coagulation disorders.
Other
- Pregnant or breastfeeding women.
- Hematoma requiring Grade II analgesics after diagnostic biopsy.
- Adults under guardianship, curatorship, or legal protection, or deprived of liberty.
- Not affiliated with a social security system.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.