Triple Negative Breast Cancer
Conditions
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.
Interventions
PROCEDURE68Ga-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.
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female with age ≥ 18 years, 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
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. Person deprived of liberty or under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the ROC curve | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances | Baseline | Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances by detecting metastases |
| Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances | Baseline | 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). |
| Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances | Day 168 | Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, separately and combined at the end of neoadjuvant treatment cycles. |
| Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances | 5 years | Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances, separately and combined at the end of the follow-up |
| Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT | Baseline | 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) |
Countries
France
Contacts
Primary ContactSandra Nespoulous
Backup ContactMarie-Emmanuelle LEGRIER
Outcome results
None listed