Clinical trial NCT06349512: 68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
Official title: 68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Triple Negative Breast Cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Female with age ≥ 18 years,
2. 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,
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:

1. Pregnant and lactating women,
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. Patients who are not affiliated to a social security system, or who are deprived of liberty, or under guardianship.
7. Person deprived of liberty or under guardianship

Primary outcomes:
measure: Area under the ROC curve
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
timeFrame: Baseline
measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
timeFrame: Baseline
measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances
timeFrame: Baseline
measure: Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT
timeFrame: Baseline
Other outcomes:
Locations:
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Paris
country: France
facility: Institut Curie -site Paris
city: Paris
country: France
facility: GH Diaconesses Croix Saint-Simon
city: Saint-cloud
country: France
facility: Institut Curie -site St Cloud
city: Saint-mande
country: France
facility: HIA Begin
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
affiliation: Institut Curie
name: Romain-David SEBAN
role: PRINCIPAL_INVESTIGATOR
References: