RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study

ConditionsRadiomic 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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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 criteria

Qualifiers

Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.

Disqualifiers

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.

Trial design

Treatments tested in this trial

Trastuzumab deruxtecan (DS-8201a)

Treatment groups

500 Participants

are divided into 1 treatment group

Locations

Fondazione IRCCS Istituto Nazionale Tumori20133, Milan Italy

Sponsors and collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

Source ClinicalTrials.gov