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

Inclusion Criteria1

  • Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.

Exclusion Criteria3

  • 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.

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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