68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
Recruiting now · Not applicable
Conditions studied: Triple Negative Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06349512
- Run by
- Institut Curie
- People needed
- 60
- Starts
- 2024-10-14
- Expected to finish
- 2032-11-30
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female with age ≥ 18 years,
- 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,
- 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.
You may not qualify if…
- Pregnant and lactating women,
- Patients with prior anti-PD(L)1 immunotherapy,
- 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,
- Person deprived of liberty or under guardianship
Where it is running
- Hôpital Privé d'Antony — Antony, France (enrolling)
- Institut Curie -site Paris — Paris, France (enrolling)
- GH Diaconesses Croix Saint-Simon — Paris, France (enrolling)
- Institut Curie -site St Cloud — Saint-Cloud, France (enrolling)
- HIA Begin — Saint-Mandé, France (enrolling)
- Hôpital FOCH — Suresnes, France (enrolling)
Full record on ClinicalTrials.gov
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