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NCT07030569Recruiting

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

Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
7 Jan 2025
Start date
Feb 2024
Primary completion date
Jan 2027
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NCT number
NCT07030569

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From Feb 2024 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not available imaging (CT scan and/or PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;

Other

  • Unknown HER2 status;
  • Node, soft tissue or other visceral as biopsy site.

Who the study is looking for

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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS Istituto Nazionale Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.