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

Conditions studied

Radiomic, Radiomics, Breast Cancer Metastatic, Breast Cancer Stage IV, Breast Carcinoma, Breast Neoplasms, Breast Cancer, Breast Cancer With Bone Metastasis, Breast Cancer With Metastatic Bone Disease, Trastuzumab, HER2, HER2 + Breast Cancer, HER2 Positive Breast Carcinoma, HER2-positive Breast Cancer, Her2/Neu Positive Advanced Solid Tumors, HER2/Neu-positive Breast Cancer

About this 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.

Interventions

• Drug: Trastuzumab deruxtecan (DS-8201a) — A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting

Primary outcomes

• HER2 protein expression (Time of the metastatic biopsy (through study completion, an average of 1 year))
• Progression-Free Survival (From treatment start to disease progression or death (through study completion, up to 5 years))

Eligibility information

Study locations

• Fondazione IRCCS Istituto Nazionale Tumori, Milan, 20133 Italy