ABCSG TR Spotlight: Validation of an Artificial Intelligence-based Prognostic Assay in ER+/HER2- Breast Cancer
Sponsor: Spotlight Medical
Trial Details
| Condition | Breast Cancer, Early Breast Cancer, ER-Positive HER2-Negative Breast Cancer |
| Intervention | Locked AI-based prognostic assay |
| Status | Active |
| Participants | 2,200 |
| Est. Completion | 31 Mar 2027 |
| Last Updated | 21 Apr 2026 |
Primary Outcome
Time to distant recurrence
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Female patients enrolled in ABCSG-8 * Postmenopausal patients with ER-positive/HER2-negative early invasive breast cancer * Available archived primary tumor material suitable for H\&E slide digitization * Available required baseline clinicopathologic variables or variables derivable according to the prespecified statistical analysis plan * Patients with permission for inclusion in this retrospective translational research study Exclusion Criteria: * No suitable archived primary tumor material for H\&E slide digitization * Missing required baseline clinicopathologic variables not recoverable according to the prespecified statistical analysis plan * No analyzable follow-up for the endpoint of interest
Trial Sites
🇦🇺 Australian Sites (1)
Countries
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