68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)

Not Applicable

Recruiting

• Conditions: Triple Negative Breast Cancer

• Registration Number: NCT06349512
• Lead Sponsor: Institut Curie

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.

Detailed Description

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

Patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. After definitive surgery, patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity.

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.

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-05
• Study Start: 2024-10-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-03
• Primary Completion: 2032-11-30
• Study Completion: 2032-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Female with age ≥ 18 years,
2. Patients with previously untreated, non-metastatic, centrally confirmed TNBC (stage T1c N1-2 or T2-4 N0-2 per AJCC) for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
3. Patients with measurable targets according to RECIST/PERCIST criteria,
4. Patients without distant metastasis based on staging 18F-FDG PET/CT,
5. Patients with tumor tissue available,
6. Patients who provided a signed written informed consent,
7. Patient ability to comply with protocol requirements,
8. Patients covered by a health insurance system.

Exclusion Criteria

1. Pregnant and lactating women,
2. Patients with prior anti-PD(L)1 immunotherapy,
3. Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
4. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
5. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
6. Patients who are not affiliated to a social security system, or who are deprived of liberty, or under guardianship.
7. Person deprived of liberty or under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Area under the ROC curve	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Comparison 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 performances by detecting metastases
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 performances by evaluating the tumor burden (TFTV : total FAP expression tumor volume and TMTV : total metabolic tumor volume).
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 predictive performances, separately and combined at the end of neoadjuvant treatment cycles.
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances	5 years	Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances, separately and combined at the end of the follow-up
Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT	Baseline	Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT imaging data, using sensitivity, specificity, positive and negative predictive values and area under the ROC curve (AUC of the ROC curve)

Trial Locations

Locations (6)

Hôpital Privé d'Antony; 🇫🇷 Antony, France

Institut Curie -site Paris; 🇫🇷 Paris, France

GH Diaconesses Croix Saint-Simon; 🇫🇷 Paris, France

Institut Curie -site St Cloud; 🇫🇷 Saint-Cloud, France

HIA Begin; 🇫🇷 Saint-Mandé, France

Hôpital FOCH; 🇫🇷 Suresnes, France