Recruiting NCT07030569

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

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Trial Parameters

Condition Radiomic

Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Type OBSERVATIONAL

Phase N/A

Enrollment 500

Sex ALL

Min Age N/A

Max Age N/A

Start Date 2024-02-01

Completion 2027-01-01

All 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

Trastuzumab deruxtecan (DS-8201a)

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Brief 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 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.

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

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