Clinical trial · Observational
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
NCT07030569CI-TRIAL-00091235RADIOSPHER2recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Metastatic | — | UNRESOLVED | — |
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer With Bone Metastasis | — | UNRESOLVED | — |
| Breast Cancer With Metastatic Bone Disease | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| HER2 | — | UNRESOLVED | — |
| HER2 + Breast Cancer | — | UNRESOLVED | — |
| Her2/Neu Positive Advanced Solid Tumors | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab deruxtecan (DS-8201a) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic breast cancer patients underwent tumor biopsy in a metastatic site
- description
- A cohort of patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting at INT with available imaging (CT scan and/or PET-FdG scan), performed from 01Jan2005 to 01Jan2024. A subgroup of this cohort is treated with Trastuzumab Deruxtecan.
- interventionNames
- Drug: Trastuzumab deruxtecan (DS-8201a)
Primary outcomes (2)
- measure
- HER2 protein expression
- timeFrame
- Time of the metastatic biopsy (through study completion, an average of 1 year)
- description
- To identify a radiomic signature ("radiobiopsy") able to predict the HER2 status on a specific metastasic site of mBC patients based on radiologic images (CT scan, PET-FdG)
- measure
- Progression-Free Survival
- timeFrame
- From treatment start to disease progression or death (through study completion, up to 5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.