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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT07030569
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan (DS-8201a) — DRUG
    A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Jan 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Metastatic breast cancer patients underwent tumor biopsy in a metastatic site
    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.

Primary Outcome Measure

HER2 protein expression [ Time Frame: Time of the metastatic biopsy (through study completion, an average of 1 year) ]

Central Contacts

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