Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Additionnal 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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