Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer

NCT07541703 · tracked via the Priya Life Science Austria tracker

Sponsor

Spotlight Medical

Phase

Observational

Started

2026-04-01

Last updated

2026-04-21

Condition(s) studied

Breast CancerEarly Breast CancerER-Positive HER2-Negative Breast Cancer

Investigational drug(s) / intervention(s)

Locked AI-based prognostic assay

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.

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Time to distant recurrence — From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.
Association of the continuous assay score and predefined risk categories with time to distant recurrence.

Trial sites (1)

Facility	City	Region	Status
Medical University of Vienna, Center of Cancer Research	Vienna	Austria

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Official registry record

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.

View NCT07541703 on ClinicalTrials.gov ↗ ← All trials in Austria