Informations générales (source: ClinicalTrials.gov)
68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer (FAP-IT)
Interventional
N/A
Institut Curie (Voir sur ClinicalTrials)
octobre 2024
novembre 2027
19 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Alexandre DE MOURA, MD | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | Nina JEHANNO, MD | Contact (sur clinicalTrials) | |||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | DELBALDO DELBALDO, MD | Contact (sur clinicalTrials) | |||
| HIA BEGIN | Audrey LEROY, MD | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | SEKKATE, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Privé d'Antony - 92160 - Antony - France | GACHET, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
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.
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