Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

NCT07570524 | Not Yet Recruiting

• 1 other identifier: 2025-4-83-004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple-negative Breast Cancer (TNBC)

Keywords

Biopsy; Residual Cancer Burden score

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

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

Study Arms (1)

Triple Negative Breast Cancer

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.

Biological: Additionnal breast biospy and blood sample

Interventions

Additionnal breast biospy and blood sample BIOLOGICAL

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

Triple Negative Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in the neoadjuvant setting for triple-negative breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Centre Eugène Marquis

Rennes, 35000, France

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antoine DELEUZE, Dr

  Centre de lutte contre le cancer Eugène Marquis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie JOLAINE

CONTACT

0299253036; v.jolaine@rennes.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2036
• Study Completion (Estimated): May 31, 2036
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)