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

RECRUITING

NCT07030569

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Summary

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2024-02-01

Completion Date

2027-01-01

Last Updated

2025-06-22

Healthy Volunteers

No

Conditions

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

Interventions

DRUG

Trastuzumab deruxtecan (DS-8201a)

A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting

Locations (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

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