Radiology-based prediction of HER2 level and T‑DXd benefit in metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RADIOSPHER2 is a single-center retrospective observational project that aims to derive a ‘‘radiobiopsy’’ radiomic signature from CT and/or FDG‑PET images to predict HER2 status across metastatic sites such as liver, lung, pleura, and bone. The radiobiopsy model will be applied to baseline scans of HER2+ and HER2‑low patients who received trastuzumab deruxtecan, assigning lesions to HER2‑0, HER2‑low, or HER2‑overexpressed groups. Investigators will compare progression-free survival between radiobiopsy-assigned cohorts using Cox regression and build multivariate models including clinical covariates. Pathology slides from biopsied metastatic sites will be reviewed and digitized for pathomics analyses to explore microscopic HER2 spatial heterogeneity and correlate imaging and tissue features.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione IRCCS Istituto Nazionale Tumori
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Claudio Vernieri, MD, PhD
• Email: claudio.vernieri@istitutotumori.mi.it
• Phone: +390223903066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.