(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Triple-negative breast cancer|Breast cancer

Inclusion criteria

• {"criterion_text":"- Female with age ≥ 18 years\n- 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,\n- Patients with measurable targets according to RECIST/PERCIST criteria\n- Patients without distant metastasis based on staging 18F-FDG PET/CT\n- Patients with tumor tissue available\n- Patients who provided a signed written informed consent,\n- Patient ability to comply with protocol requirements\n- Patients covered by a health insurance system"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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)..","definition_or_measurement_approach":"Performance measured as Area under the ROC curve (AUC of the ROC curve) for predicting complete histological response after neoadjuvant chemotherapy plus pembrolizumab."}

Secondary endpoints

• {"endpoint_text":"- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances for: - detection of metastases (using the total number of metastatic lesion), - Evaluation of the tumor burden (using the total FAP expression tumor volume/TFTV* and the total metabolic tumor volume/TMTV*, respectively).","definition_or_measurement_approach":"Detection of metastases measured using total number of metastatic lesions; tumor burden evaluated using total FAP expression tumor volume (TFTV) and total metabolic tumor volume (TMTV)."}
• {"endpoint_text":"- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, separately and combined (association of biomarkers extracted from 68Ga-FAPI-46 PET/CT imaging, 18F-FDG PET/CT imaging with response to treatment).","definition_or_measurement_approach":"Predictive performance assessed by association of imaging-derived biomarkers with response to treatment (histological response)."}
• {"endpoint_text":"- Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT prognostic performances, separately and combined (association of biomarkers extracted from 68Ga-FAPI-46 PET/CT imaging, 18F-FDG PET/CT imaging with recurrence and/or death from breast cancer).","definition_or_measurement_approach":"Prognostic performance assessed by association of imaging-derived biomarkers with risk of tumor recurrence and/or death from breast cancer."}
• {"endpoint_text":"- Assessment of the 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 curve the ROC curve(AUC of the ROC curve).","definition_or_measurement_approach":"Model performance metrics: sensitivity, specificity, positive predictive value, negative predictive value, and AUC of ROC."}
• {"endpoint_text":"- Exploratory: Correlation of 68Ga-FAPI-46 PET/CT imaging data with histological evaluation of CAF subpopulations (immunohistochemical staining for FAP), immune microenvironment (PD-L1 staining and TILs analysis) and comparison of the sensibility of 68Ga-FAPI-46 PET/CT imaging with that of histology.","definition_or_measurement_approach":"Correlation analyses between PET/CT imaging biomarkers and histological markers (IHC for FAP, PD-L1, TILs); comparison of sensitivity of imaging versus histology."}
• {"endpoint_text":"- Exploratory: Quantitative analyze of circulating tumor DNA (ctDNA) before and after neoadjuvant treatment (pre-surgery), and correlation of them with biomarkers extracted from initial PET/CT scans (68Ga-FAPI-46 + 18F-FDG) on the one hand, and histological response on the other.","definition_or_measurement_approach":"Quantitative analysis of ctDNA pre- and post-neoadjuvant treatment and correlation with imaging biomarkers and histological response."}

France

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

655

Number Of Sites

6

Number Of Participants

300

Primary sponsor

Full Name

Institut Curie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France