RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
Recruiting · NCT07030569 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
View the official record on ClinicalTrials.gov →Interventions studied
Trastuzumab deruxtecan (DS-8201a)
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Fondazione IRCCS Istituto Nazionale Tumori - Milan, Italy