Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer (PRIME-TNBC)

April 30, 2026 updated by: Center Eugene Marquis

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Immune Determinants According to Response to Neoadjuvant Immunochemotherapy
Time Frame: 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).
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)
Time Frame: 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.
From baseline (pre-treatment) through 5 years of follow-up.
Comparison of Immune Determinants According to Overall Survival (OS)
Time Frame: 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.
From baseline (pre-treatment) through 5 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Antoine DELEUZE, Dr, Centre de lutte contre le cancer Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2036

Study Completion (Estimated)

May 31, 2036

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-4-83-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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