Real-World, Multicenter Assessment of 18F-FDG PET/CT Prognostic Value in Triple-Negative Breast Cancer (TRINE-PET): the Study Protocol

Purpose Triple-negative breast cancer (TNBC) represents a highly aggressive subtype of breast cancer with limited therapeutic options. [ ¹⁸ F]FDG PET/CT has shown potential in evaluating disease extension and treatment response in breast cancer, but its prognostic role and the impact on treatment management in TNBC remains unclear. Therefore, a large experience is highly desired to solve some clinical needs in this subset of breast cancer. Methods A retrospective, multicenter, real-world observational study will be conducted, enrolling TNBC patients from various nuclear medicine centers across Italy, supported by the Italian Association of Nuclear Medicine, Molecular Imaging and Therapy. Imaging and clinical data will be collected and analyzed. Statistical analysis will be performed in accordance with the distribution of the study population. MedCalc software will be used for computing each collected variables and for testing all the endpoints. Expected results: [ ¹⁸ F]FDG PET/CT may provide valuable prognostic insights, particularly in stratifying TNBC patients according to their risk of progression and death and aiding treatment decisions. Conclusion Understanding the prognostic implications of [ ¹⁸ F]FDG PET/CT in TNBC may contribute to personalize treatment strategies.