NCT06349512Recruiting
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Mar 2024
- Start date
- 14 Oct 2024
- Primary completion date
- 30 Nov 2032
- Lead sponsor
- Institut Curie
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06349512
- EU CT number
- 2023-507860-37-00
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 14 Oct 2024 to the primary completion date, 30 Nov 2032
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior anti-PD(L)1 immunotherapy,
- Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
Other illness
- Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
Other
- Pregnant and lactating women,
- Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
- Person deprived of liberty or under guardianship
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Prive D Antony Coordinator of this site? Confirm its status | Antony | France | Recruiting |
| Gh Diaconesses Croix Saint Simon Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| INSTITUT CURIE_Site Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut Curie - site St-Cloud Coordinator of this site? Confirm its status | Saint-Cloud | France | Recruiting |
| HIA Begin Coordinator of this site? Confirm its status | Saint-Mandé | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.