RecruitingNCT07030569

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


Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

500 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This is a data analysis study using imaging (CT and PET scans) to build a model that can predict whether a metastatic breast cancer tumor is HER2-positive and whether a targeted drug called T-DXd will work for that patient. **You may be eligible if:** - You have metastatic breast cancer - You had a biopsy from the liver, lung, lining of the chest, or bone in the metastatic setting, done between January 2005 and January 2024 - You have CT or PET-FDG scan images taken within 3 months before your biopsy or before your last treatment was stopped **You may NOT be eligible if:** - You do not have the required imaging available - Your HER2 status is unknown - Your biopsy was taken from a lymph node, soft tissue, or another organ not listed (liver, lung, pleura, or bone) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab 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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NCT07030569


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