Trial · NCT07030569
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
NCT07030569, Recruiting, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study. Trials, record NCT07030569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07030569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
- NCT number
- NCT07030569
- Status
- Recruiting
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- 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
- Trastuzumab deruxtecan (DS-8201a)
- First posted
- 2025-06-22
- Last updated
- 2025-06-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HER2 protein expression | Time of the metastatic biopsy (through study completion, an average of 1 year) | 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) |
| Primary | Progression-Free Survival | From treatment start to disease progression or death (through study completion, up to 5 years) | To test the accuracy of "radiobiopsy" in predicting PFS in a cohort of metastatic breast cancer patients treated with trastuzumab deruxtecan. |
| Secondary | HER2 intratumoral heterogeneity | Time of the metastatic biopsy (through study completion, an average of 1 year) | To identify a pathomic-based model able to predict intratumoral HER2 heterogeneity on pathology slides of HER2-positive and HER2-low mBC patients |
| Secondary | HER2 interlesional heterogeneity | Time of the metastatic biopsy (through study completion, an average of 1 year) | To test the concordance between intratumoral and inter-lesional HER2 heterogeneity in HER2-positive and HER2-low mBC patients. |
| Secondary | Radiomics agnostic features | Time of the imaging next to the metastatic biopsy (through study completion, an average of 1 year) | To correlate the features included in the radiomic model with the transcriptomics data obtain from bulk-RNAseq from biopsies, in order to explain agnostic features discovered with radiomics. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07030569
GET https://conductscience.org/api/trials/v1/NCT07030569/registered