NCT06349512

Brief Summary

Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
80mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Oct 2024Nov 2032

First Submitted

Initial submission to the registry

March 25, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2032

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

8.1 years

First QC Date

March 25, 2024

Last Update Submit

December 15, 2025

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Area under the ROC curve

    To measure the performance of 68Ga-FAPI-46 PET/CT imaging to predict complete histological response after neoadjuvant chemotherapy plus Pembrolizumab, in terms of Area under the ROC curve (AUC of the ROC curve).

    6 months

Secondary Outcomes (5)

  • Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances

    Baseline

  • Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances

    Baseline

  • Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances

    Day 168

  • Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances

    5 years

  • Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT

    Baseline

Study Arms (1)

Triple Negative Breast Cancer

EXPERIMENTAL

Patients with early-stage high-risk Triple Negative Breast Cancer

Procedure: 68Ga-FAPI-46 PET/CT imaging

Interventions

68Ga-FAPI-46 PET/CT imagingPROCEDURE

The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.

Triple Negative Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female are included
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female with age ≥ 18 years,
  • Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
  • Patients with measurable targets according to RECIST/PERCIST criteria,
  • Patients without distant metastasis based on staging 18F-FDG PET/CT,
  • Patients with tumor tissue available,
  • Patients who provided a signed written informed consent,
  • Patient ability to comply with protocol requirements,
  • Patients covered by a health insurance system.

You may not qualify if:

  • Pregnant and lactating women,
  • Patients with prior anti-PD(L)1 immunotherapy,
  • Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
  • Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
  • Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
  • Person deprived of liberty or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Privé d'Antony

Antony, 92160, France

RECRUITING

Institut Curie -site Paris

Paris, 75005, France

RECRUITING

GH Diaconesses Croix Saint-Simon

Paris, 75020, France

RECRUITING

Institut Curie -site St Cloud

Saint-Cloud, 92210, France

RECRUITING

HIA Begin

Saint-Mandé, 94160, France

RECRUITING

Hôpital FOCH

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Romain-David SEBAN

    Institut Curie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Nespoulous

CONTACT

0147111654drci.promotion@curie.fr

Marie-Emmanuelle LEGRIER

CONTACT

0156245649drci.promotion@curie.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 5, 2024

Study Start

October 14, 2024

Primary Completion (Estimated)

November 30, 2032

Study Completion (Estimated)

November 30, 2032

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accrodance with Institut Curie policies.

Shared Documents
STUDY PROTOCOL
Time Frame
Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR(6)