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

What this Trial Is About

Researchers are evaluating how well a special imaging scan called 68Ga-FAPI-46 PET/CT can predict the response of early-stage high-risk triple-negative breast cancer (TNBC) to treatment before starting therapy. This study focuses on patients receiving a combination of pembrolizumab, a type of immunotherapy, with chemotherapy as a standard care approach. The study is prospective and involves multiple centers collaborating to understand treatment outcomes better. Patients will receive pembrolizumab at a dose of 200 mg every three weeks alongside 4 cycles of paclitaxel plus carboplatin chemotherapy, followed by 4 cycles of either doxorubicin or epirubicin plus cyclophosphamide. After surgery to remove the tumor, participants will continue with up to 9 cycles of pembrolizumab as adjuvant therapy or until cancer returns or unacceptable side effects occur. Before treatment begins, each patient will have a 68Ga-FAPI-46 PET/CT scan performed within 14 days, using the same machine as the standard 18F-FDG PET/CT scan. During the study, researchers will collect imaging data and monitor patients throughout the entire treatment and follow-up period. They will assess how well the imaging scan predicts the tumor's histological response to therapy by measuring outcomes such as the area under the ROC curve at 6 months. The study will also compare the predictive and prognostic performance of the 68Ga-FAPI-46 PET/CT scan against the standard 18F-FDG PET/CT scan. Participants will be followed closely for safety and treatment response during the neoadjuvant, surgical, and adjuvant phases of care, with the study ending by November 2032.

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