NCT07030569 RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
| NCT ID | NCT07030569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Radiomic |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-02-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07030569 clinical trial?
This trial is open to participants of all sexes, studying Radiomic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07030569 currently recruiting?
Yes, NCT07030569 is actively recruiting participants. Contact the research team at claudio.vernieri@istitutotumori.mi.it for enrollment information.
Where is the NCT07030569 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07030569 clinical trial?
NCT07030569 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The trial plans to enroll 500 participants.