Triple-negative Breast Cancer (TNBC)
Conditions
Keywords
Biopsy, Residual Cancer Burden score
Brief 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.
Interventions
BIOLOGICALAdditionnal breast biospy and blood sample
Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up.
Sponsors
Center Eugene Marquis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy | Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up). | 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). |
| Comparison of Immune Determinants According to Progression-Free Survival (PFS) | From baseline (pre-treatment) through 5 years of follow-up. | omparison of immune determinants between patients with different progression-free survival (PFS) outcomes. PFS is defined as the time from the start of neoadjuvant treatment to the first occurrence of tumor recurrence, evaluated according to RECIST v1.1 criteria. |
| Comparison of Immune Determinants According to Overall Survival (OS) | From baseline (pre-treatment) through 5 years of follow-up | Comparison of immune determinants between patients with different overall survival (OS) outcomes. OS is defined as the time from the start of neoadjuvant treatment to death from any cause. |
Countries
France
Contacts
CONTACTValérie JOLAINE
PRINCIPAL_INVESTIGATORAntoine DELEUZE, Dr
Centre de lutte contre le cancer Eugène Marquis
Outcome results
None listed