Trial Title:
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)
NCT ID:
NCT06349512
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
FAPI-46
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
68Ga-FAPI-46 PET/CT imaging
Description:
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.
Arm group label:
Triple Negative Breast Cancer
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Only female are included
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Privé d'Antony
Address:
City:
Antony
Zip:
92160
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
GACHET, MD
Investigator:
Last name:
Julie GACHET, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie -site Paris
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alexandre DE MOURA, MD
Investigator:
Last name:
Alexandre DE MOURA, MD
Email:
Principal Investigator
Facility:
Name:
GH Diaconesses Croix Saint-Simon
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
DELBALDO DELBALDO, MD
Investigator:
Last name:
DELBALDO DELBALDO, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie -site St Cloud
Address:
City:
Saint-cloud
Zip:
92210
Country:
France
Status:
Recruiting
Contact:
Last name:
Nina JEHANNO, MD
Investigator:
Last name:
Nina JEHANNO, MD
Email:
Principal Investigator
Facility:
Name:
HIA Begin
Address:
City:
Saint-mande
Zip:
94160
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Audrey LEROY, MD
Investigator:
Last name:
Audrey LEROY, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital FOCH
Address:
City:
Suresnes
Zip:
92150
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
SEKKATE, MD
Investigator:
Last name:
Sakina SEKKATE, MD
Email:
Principal Investigator
Start date:
October 14, 2024
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06349512
