Triple Negative Breast CancerFAP-ITNCT06349512
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
A study testing 68Ga-FAPI-46 PET/CT imaging in people with Triple Negative Breast Cancer, run by Institut Curie at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- 68Ga-FAPI-46 PET/CT imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesFrance
- Study dates
- 14 Oct 2024to 30 Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Hôpital Privé d'Antony
Antony, 92160
Amal GHOUADNI, MD
Amal GHOUADNI, MD
- Recruiting
Institut Curie -site Paris
Paris, 75005
Nina JEHANNO, MD
Nina JEHANNO, MD
- Recruiting
GH Diaconesses Croix Saint-Simon
Paris, 75020
Laure HIRSCH, MD
Laure HIRSCH, MD
- Recruiting
Institut Curie -site St Cloud
Saint-Cloud, 92210
Alexandre DE MOURA, MD
Alexandre DE MOURA, MD
- Recruiting
HIA Begin
Saint-Mandé, 94160
Hugo PICCHI, MD
Hugo PICCHI, MD
- Recruiting
Hôpital FOCH
Suresnes, 92150
SEKKATE, MD
Sakina SEKKATE, MD
About this study
Official title: 68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer
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.
Read the detailed description
Prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
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
- Triple Negative Breast Cancer
- Being tested
- 68Ga-FAPI-46 PET/CT imaging
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-46 PET/CT imagingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast Cancer | Experimental | Patients with early-stage high-risk Triple Negative Breast Cancer Receives: Procedure: 68Ga-FAPI-46 PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ROC curve
To measure the performance of 68Ga-FAPI-46 PET/CT imaging to predict complete histological response after neoadjuvant chemotherapy plus Pembrolizumab, in terms of Area under the ROC curve (AUC of the ROC curve).
Measured: 6 months
Secondary outcomes (5)
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances by detecting metastases
Measured: Baseline
Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances by evaluating the tumor burden (TFTV : total FAP expression tumor volume and TMTV : total metabolic tumor volume).
Measured: Baseline
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, separately and combined at the end of neoadjuvant treatment cycles.
Measured: Day 168
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances, separately and combined at the end of the follow-up
Measured: 5 years
Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT
Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT imaging data, using sensitivity, specificity, positive and negative predictive values and area under the ROC curve (AUC of the ROC curve)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start14 Oct 2024
- Primary completion30 Nov 2032 (estimated)
- Study completion30 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain-David SEBAN, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349512
- Sponsor's protocol ID
- IC 2022-07
- Other IDs
- 2023-507860-37-00, 2023
- Acronym
- FAP-IT
- Status last verified
- Dec 2025
- First submitted
- 25 Mar 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accrodance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06349512
- Acronym / sponsor ID
- FAP-IT / IC 2022-07
- Conditions
- Triple Negative Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Nov 2032 (estimated)
- Study completion
- 30 Nov 2032 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancer | Experimental | Procedure: 68Ga-FAPI-46 PET/CT imagingPatients with early-stage high-risk Triple Negative Breast Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI-46 PET/CT imagingThe 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. | Procedure or surgery | Triple Negative Breast Cancer |
Primary outcome
Area under the ROC curve
Time frame: 6 months
To measure the performance of 68Ga-FAPI-46 PET/CT imaging to predict complete histological response after neoadjuvant chemotherapy plus Pembrolizumab, in terms of Area under the ROC curve (AUC of the ROC curve).
5 secondary outcomes
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
Time frame: Baseline
Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
Time frame: Baseline
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances
Time frame: Day 168
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances
Time frame: 5 years
Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accrodance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain-David SEBAN principal investigator
Institut Curie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI-46 PET/CT imaging in people with Triple Negative Breast Cancer, run by Institut Curie at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Nespoulous (0147111654, drci.promotion@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC curve (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.