68Ga-FAPI-46 PET/CT for predicting histological response in triple-negative breast cancer
- Conditions
- Breast cancerTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507860-37-00
- Lead Sponsor
- Institut Curie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Female with age = 18 years, 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,, 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
Patients with prior anti-PD(L)1 immunotherapy, Pregnant and lactating women, 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, Patients who are not affiliated to a social security system, or who are deprived of liberty, or under guardianship, Person deprived of liberty or under guardianship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method