68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
NCT ID: NCT06349512
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-14
2032-11-30
Brief Summary
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Detailed Description
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Patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. After definitive surgery, patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity.
The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Triple Negative Breast Cancer
Patients with early-stage high-risk Triple Negative Breast Cancer
68Ga-FAPI-46 PET/CT imaging
The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.
Interventions
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68Ga-FAPI-46 PET/CT imaging
The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.
Eligibility Criteria
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Inclusion Criteria
2. 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,
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.
Exclusion Criteria
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. Person deprived of liberty or under guardianship
18 Years
FEMALE
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Romain-David SEBAN
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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Hôpital Privé d'Antony
Antony, , France
Institut Curie -site Paris
Paris, , France
GH Diaconesses Croix Saint-Simon
Paris, , France
Institut Curie -site St Cloud
Saint-Cloud, , France
HIA Begin
Saint-Mandé, , France
Hôpital FOCH
Suresnes, , France
Countries
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Central Contacts
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Facility Contacts
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Amal GHOUADNI, MD
Role: primary
Nina JEHANNO, MD
Role: primary
Laure HIRSCH, MD
Role: primary
Alexandre DE MOURA, MD
Role: primary
Hugo PICCHI, MD
Role: primary
SEKKATE, MD
Role: primary
Other Identifiers
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2023-507860-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
IC 2022-07
Identifier Type: -
Identifier Source: org_study_id