Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07541703

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms ER-Positive HER2-Negative Breast Cancer Early Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Medical University of Vienna, Center of Cancer Research

Vienna, Austria

About this study

This is an independent, external, blinded, retrospective validation study of a locked AI-based prognostic assay in ER-positive/HER2-negative EBC.

The source population consists of eligible patients from ABCSG-8 with available archived tumor material suitable for H&E slide digitization, with extended follow-up from ABCSG-16 where available. Primary analyses will be conducted in patients with slides that pass prespecified quality control and with required baseline clinicopathologic variables available or derivable according to the prespecified statistical analysis plan.

The assay generates a continuous prognostic score and predefined risk categories using one digitized H&E-stained surgical resection slide together with routine baseline clinicopathologic variables. Spotlight Medical will generate assay predictions while blinded to clinical outcomes. ABCSG will conduct the statistical analyses according to a prespecified protocol and statistical analysis plan.

The primary objective is validation of the association of the assay with time to distant recurrence. Secondary objectives are validation of the association of the assay with disease-free survival and overall survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locked AI-based prognostic assay

Diagnostic Test

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.

Primary outcomes

  1. Time to distant recurrence

    Time frame: 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.

Secondary outcomes

  1. Disease-free survival

    Time frame: From ABCSG-8 randomization to first disease-free survival event, assessed up to 15 years.

    Association of the continuous assay score and predefined risk categories with disease-free survival.

  2. Overall survival

    Time frame: From ABCSG-8 randomization to death from any cause, assessed up to 15 years.

    Association of the continuous assay score and predefined risk categories with overall survival.

Other outcomes

  1. Early distant recurrence (0 to 5 years)

    Time frame: From ABCSG-8 randomization to distant recurrence within 5 years after randomization.

    Association of the continuous assay score and predefined risk categories with time to distant recurrence during the first 5 years after randomization.

  2. Late distant recurrence (>5 years, landmark analysis)

    Time frame: From 5 years after ABCSG-8 randomization to distant recurrence, assessed from year 5 up to 15 years after randomization.

    Association of the continuous assay score and predefined risk categories with time to distant recurrence beyond 5 years after randomization, assessed using a landmark analysis among patients event-free at 5 years.

  3. Treatment-by-assay interaction for distant recurrence

    Time frame: From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.

    Assessment of the interaction between randomized treatment and the continuous assay score or predefined risk categories for time to distant recurrence.

Sponsors and collaborators

Lead sponsor

Spotlight Medical

Industry

Collaborators

  • Austrian Breast & Colorectal Cancer Study Group

Registry information

Official study title

ABCSG TR Spotlight: Validation of an Artificial Intelligence-based Prognostic Assay in ER+/HER2- Breast Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.