An observational study in Radiomic, Radiomics and Breast Cancer Metastatic, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational
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Among 27 studies in Breast Neoplasms by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano — 9 open to participants now, 10 under way, none of them phase 3. Breast Neoplasms · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Among the 27 studies in Breast Neoplasms by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, this one is one of 2 that started in 2024, is one of 8 observational ones, and was the 25th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →9 of the 27 studies in Breast Neoplasms by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano are open now, in 1 country. Recruiting first, the newest first:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Sites in Italy
Ages 18+ · Women only
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Sites in Italy
Ages 18+
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Sites in Italy
Ages 18–85 · Women only · Healthy volunteers
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Sites in Italy
Ages 18–75 · Women only
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Sites in Italy
Ages 18+
By country, each count listing its studies:
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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27 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 224 across the 19 interventional studies, 537 across the 8 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
2 of the studies in Breast Neoplasms by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05621837Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoQuantifying Systemic Immunosuppression to Personalize Cancer Therapy | 2026-12-31 |
| NCT07030569Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoRADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study | 2027-01-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 27 studies in Breast Neoplasms by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
The primary objective of the study is the identification of a radiomic signature ("radiobiopsy") from several features extracted from radiological images to predict the HER2 status on different specific metastatic sites of metastatic breast cancer patients. Accordingly to the study rationale, it will chosen to analyse images from those metastatic sites usually difficulty to approach with biopsy, such as lung, liver, pleural and bone lesions.
The "radiobiopsy" model will be applied to retrospectively calculate HER2 status from the baseline scan of HER2+ or HER2-low mBC patients underwent any-line trastuzumab deruxtecan (T-DXd) treatment for metastatic disease. The T-DXd PFS of patients assigned to the three cohorts (HER2-0, HER2-low or HER2-overexpressed) based on "radiobiopsy" model will be then calculated and differences among groups will be tested with Cox regression analysis. Clinical characteristics (e.g., number of therapy line for metastatic disease, HR status, HER2 IHC expression) of the same cohort will be extracted from clinical health records, in order to build a multivariate Cox regression model.
To assess the HER2 spatial heterogeneity at intra-tumor microscopic level, pathology slides derived from biopsies of patients enrolled to build the "radiobiopsy" model will be also reviewed from pathologists for HER2 heterogeneity evaluation and digitalized for pathomics analyses. The HER2 heterogeneity will be evaluated by pathologist based on IHC expression and distribution. In order to evaluate if radiomic features can predict HER2 heterogeneity at intra-tumor macroscopic level, a different radiomic model will be developed for this purpose, using the HER2 heterogeneity score assigned by pathologist in the previous task as outcome.
In addition, in order to confirm and quantify inter-lesion HER2 spatial heterogeneity, the features included in the discovered "radiobiopsy" signature will be extracted and the HER2 status calculated for the other metastatic lesions. A correlation analysis between HER2 status assignment from different lesions of the same patients will be performed to quantify the prevalence of HER2 variability among lesions in the cohort. In order to clarify if HER2 heterogeneity at microscopic level is associated with inter-lesion heterogeneity, a single-patient correlations between the heterogeneity pathomic score and the inter-lesion radiomic heterogeneity will be performed.
To have insight into the features included into the "radiobiopsy" model, transcriptomics analysis will be conducted through bulk-RNA sequencing from available tumor FFPE specimens of lung, pleural and liver biopsies. The differential expression of several genes and transcriptomic signatures with known prognostic/predictive relevance, such as immune and metabolic genes and signatures, will be assessed among samples with differently expressed features included in the model. It will allow to dissect tumor biology by finding the biological counterpart of agnostic radiomics features that would remain otherwise unexplained.
The population of the study will consists with a cohort of patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting at the Sponsor Institution with available imaging (CT scan and/or PET-FdG scan), performed from 01Jan2005 to 01Jan2024.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Trastuzumab deruxtecan (DS-8201a)
A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting
HER2 protein expression
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)
Time frame: Time of the metastatic biopsy (through study completion, an average of 1 year)
Progression-Free Survival
To test the accuracy of "radiobiopsy" in predicting PFS in a cohort of metastatic breast cancer patients treated with trastuzumab deruxtecan.
Time frame: From treatment start to disease progression or death (through study completion, up to 5 years)
HER2 intratumoral heterogeneity
To identify a pathomic-based model able to predict intratumoral HER2 heterogeneity on pathology slides of HER2-positive and HER2-low mBC patients
Time frame: Time of the metastatic biopsy (through study completion, an average of 1 year)
HER2 interlesional heterogeneity
To test the concordance between intratumoral and inter-lesional HER2 heterogeneity in HER2-positive and HER2-low mBC patients.
Time frame: Time of the metastatic biopsy (through study completion, an average of 1 year)
Radiomics agnostic features
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.
Time frame: Time of the imaging next to the metastatic biopsy (through study completion, an average of 1 year)
Plan to share: Undecided
Started Feb 2024 (actual). Primary completion is estimated for Jan 2027, 35 months after the start.
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