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Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer
Sponsor: Spotlight Medical
Summary
This retrospective observational study evaluates the prognostic performance of a locked Artificial Intelligence (AI)-based assay in patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative early breast cancer (EBC) from Austrian Breast \& Colorectal Cancer Study Group (ABCSG)-8, with extended follow-up from ABCSG-16 where available. ABCSG will provide digitized hematoxylin and eosin (H\&E) slides and required baseline clinicopathologic variables to Spotlight Medical without outcome data for blinded assay inference. ABCSG will then perform the prespecified statistical analyses linking assay outputs to clinical outcomes.
Official title: ABCSG TR Spotlight: Validation of an Artificial Intelligence-based Prognostic Assay in ER+/HER2- Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
2200
Start Date
2026-04-01
Completion Date
2028-03-31
Last Updated
2026-04-21
Healthy Volunteers
No
Interventions
Locked AI-based prognostic assay
A locked AI-based assay applied to one digitized H\&E-stained surgical resection slide and routine baseline clinicopathologic variables to generate a continuous prognostic score and predefined risk categories.
Locations (1)
Medical University of Vienna, Center of Cancer Research
Vienna, Austria