RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study

RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.

NCT Number	NCT07030569
Lead Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions	Radiomic, Radiomics, Breast Cancer Metastatic, Breast Cancer Stage IV, Breast Carcinoma, Breast Neoplasms, Breast Cancer, Breast Cancer With Bone Metastasis +8 more
Enrollment	500 participants
Start Date	2024-02-01
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-22