Clinical trial · Observational
Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple-negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additionnal breast biospy and blood sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Triple Negative Breast Cancer
- description
- The study will include an initial assessment and longitudinal and individual follow-up to identify the occurrence of clinical events of interest and to monitor the evolution of any tumour biomarkers on circulating tumour DNA.
- interventionNames
- Biological: Additionnal breast biospy and blood sample
Primary outcomes (3)
- measure
- Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy
- timeFrame
- Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up).
- description
- Comparison of immune determinants (cellular and molecular) in tumor and blood samples between patients achieving pathological complete response (pCR, RCB-0) and those with partial/non-response (RCB-I, II, III).
- measure
- Comparison of Immune Determinants According to Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available