68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)

Triple Negative Breast Cancer Clinical Trial

— FAP-IT  

Official title:

68Ga-FAPI-46 PET/CT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349512
• Other study ID #: IC 2022-07
• Secondary ID: 2023-507860-37-0
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: July 30, 2027

Study information

• Verified date: April 2024
• Source: Institut Curie
• Contact: Sandra Nespoulous
• Phone: 0147111654
• Email: drci.promotion[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months
Secondary	Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances	Detection of metastases (using the total number of metastatic lesion)	Baseline
Secondary	Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances	Evaluation of the tumor burden (using the total FAP expression tumor volume/TFTV* and the total metabolic tumor volume/TMTV*, respectively).	Baseline
Secondary	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.	Baseline
Secondary	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)	Baseline