Radiological Prediction of Response to Neoadjuvant Chemoimmunotherapy for Triple-negative Breast Cancer

NCT06879704 | Recruiting

• 1 other identifier: CHB24.03
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to find the best imaging technique, alone or in combination, that can best predict a complete response (absence of tumour cells). It also seems important to identify blood markers able to predict which patients will benefit most from treatment, with a view to personalising them, or which patients will be most at risk of toxicities, particularly related to immunotherapy, with a view to personalising monitoring.

Conditions

Triple Negative Breast Cancer

Keywords

Triple Negative Breast Cancer; chemo-immunotherapy; radiological prediction

Outcome Measures

Primary Outcomes (1)

• concordance rate between quadrimodal radiological assessment (ultrasound, angiography/mammography, MRI, PET-CT) and histologically-obtained response following neoadjuvant chemo-immunotherapy in patients with triple-negative breast cancer (TNBC).

  concordance of the response between radiological assessement and histological response

  two weeks after surgery

Study Arms (1)

PRECISION ARM

EXPERIMENTAL

Patient will have four imaging exam : MRI, PET-scan, ultrasound and angio/Mammography

Other: Imaging assessment

Interventions

Imaging assessment OTHER

The patient will have four imaging exam : Ultrasound, angio/mammography, MRI and PET-scan

PRECISION ARM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Patient with histologically proven TNBC
• Indication for neo-adjuvant chemo-immunotherapy treatment
• Age between 18 and 75
• Affiliated or beneficiary of a social protection scheme

You may not qualify if:

• Pregnant or breast-feeding women
• Contraindication to immunotherapy
• Inflammatory breast cancer (T4d)
• Metastatic patients
• Allergies to iodine or gadolinium
• Patient with an augmentation prosthesis (for angiography/mammography)
• Claustrophobic patients
• Renal contraindication to contrast products according to SFR-CIRTACI
• Ferromagnetic material
• Uncontrolled diabetes (blood glucose \>10 mmol/L)
• Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
• Patient under guardianship, curatorship or safeguard of justice

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Florian Clatot, Md, PhD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Clatot, MD, PhD

CONTACT

+33276673004; florian.clatot@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 17, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): November 28, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)