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

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial, called RADIOSPHER2, is studying a new way to use medical images (like CT and PET scans) to better understand a protein called HER2 in patients with metastatic breast cancer—that means cancer that has spread to other parts of the body. Researchers want to see if patterns in these images can help predict how much HER2 is present and how well a specific treatment called trastuzumab deruxtecan might work. This could help doctors choose the best treatment by looking at how HER2 changes over time and in different areas of the body.

The study is open to patients of any gender who have metastatic breast cancer and had a biopsy (a small sample taken for testing) from the liver, lungs, pleura (lining of the lungs), or bones between January 2005 and January 2024. To join, patients must also have had recent CT or PET scans within three months before their biopsy or last treatment break. Participants can expect their past scans and biopsy results to be reviewed to help find new ways to predict treatment success. This study does not involve new treatments but focuses on learning from existing information to improve future care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.
• Exclusion Criteria:
• • Not available imaging (CT scan and/or PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;
• • Unknown HER2 status;
• • Node, soft tissue or other visceral as biopsy site.