RadiomicRadiomicsBreast Cancer MetastaticBreast Cancer Stage IVBreast CarcinomaBreast NeoplasmsBreast CancerBreast Cancer With Bone MetastasisBreast Cancer With Metastatic Bone DiseaseTrastuzumabHER2HER2 + Breast CancerHER2 Positive Breast CarcinomaHER2-positive Breast CancerHer2/Neu Positive Advanced Solid TumorsHER2/Neu-positive Breast Cancer
Trastuzumab deruxtecan (DS-8201a): A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting
Study 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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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)
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.
Trial sites (1)
Facility
City
Region
Status
Fondazione IRCCS Istituto Nazionale Tumori
Milan
Italy
Recruiting
More Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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