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

Launched by INSTITUT CURIE · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called FAP-IT, is studying a new imaging technique called 68Ga-FAPI-46 PET/CT to see if it can help predict how well patients with triple-negative breast cancer (TNBC) will respond to treatment. Specifically, the trial is looking at women with early-stage, high-risk TNBC who are about to start a standard treatment that combines chemotherapy with a drug called pembrolizumab. The goal is to determine if this imaging method can provide valuable information before treatment begins, which could help doctors tailor the best approach for each patient.

To participate in this study, women must be at least 18 years old, have been diagnosed with non-metastatic TNBC, and have not received prior treatment for their cancer. They also need to have measurable tumor targets and be able to provide consent for participation. Throughout the trial, participants can expect to undergo imaging tests and receive the standard neoadjuvant treatment. It's important to note that pregnant or breastfeeding women, as well as those with certain medical conditions or previous treatments, are not eligible to join. This study aims to improve care for patients with triple-negative breast cancer, and participants will play a vital role in advancing this research.

Gender

FEMALE

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