Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

Center Eugene Marquis200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Triple-negative Breast Cancer (TNBC)

Interventions

Additionnal breast biospy and blood sampleBIOLOGICAL

Tumor biopsy during intra-tumoral clip placement (pre-treatment) and annual blood samples (20 mL) for 5 years, in addition to standard follow-up.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy

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).

Time frame: Baseline (pre-treatment tumor biopsy) and up to 5 years (annual blood samples and clinical follow-up).

Comparison of Immune Determinants According to Progression-Free Survival (PFS)

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.

Time frame: From baseline (pre-treatment) through 5 years of follow-up.

Comparison of Immune Determinants According to Overall Survival (OS)

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.

Time frame: From baseline (pre-treatment) through 5 years of follow-up