Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07570524

Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Triple-Negative Breast Cancer (TNBC) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Eugène Marquis

Rennes, 35000, France

Location status: Recruiting

Location contact

Antoine DELEUZE, Dr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie JOLAINE

CONTACT

[email protected]

0299253036 ext. +33

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Acronym: PRIME-TNBC

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
May 6, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.