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

Institut Curie60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Triple Negative Breast Cancer

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female with age ≥ 18 years, 2. 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, 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. Person deprived of liberty or under guardianship

Locations (6)

Hôpital Privé d'Antony

Antony, France

RECRUITING

Institut Curie -site Paris

Paris, France

RECRUITING

GH Diaconesses Croix Saint-Simon

Paris, France

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

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

Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances by detecting metastases

Time frame: Baseline

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

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).

Time frame: Baseline

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

Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, separately and combined at the end of neoadjuvant treatment cycles.

Time frame: Day 168

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

Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances, separately and combined at the end of the follow-up

Time frame: 5 years

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

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)

Time frame: Baseline

Central Contacts

Sandra Nespoulous

CONTACT

0147111654 drci.promotion@curie.fr

Marie-Emmanuelle LEGRIER

CONTACT

0156245649 drci.promotion@curie.fr

Data from ClinicalTrials.gov

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