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

NCT07030569 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-06-22

No results posted yet for this study

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.

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

DRUG

Trastuzumab deruxtecan (DS-8201a)

A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07030569 on ClinicalTrials.gov