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

April 16, 2026 updated by: Spotlight Medical

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna, Center of Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women with hormone receptor-positive early breast cancer enrolled in ABCSG-8, restricted in this validation study to the ER-positive/HER2-negative subgroup with available archived tumor material and required baseline clinicopathologic variables.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eligible ABCSG-8 cohort
Eligible patients from ABCSG-8 within the ER-positive/HER2-negative validation population, with available tumor material for H&E digitization and required baseline clinicopathologic variables, and with extended clinical follow-up from ABCSG-16 where available.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From ABCSG-8 randomization to first disease-free survival event, assessed up to 15 years.
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.
From ABCSG-8 randomization to death from any cause, assessed up to 15 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From ABCSG-8 randomization to distant recurrence within 5 years after randomization.
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.
From 5 years after ABCSG-8 randomization to distant recurrence, assessed from year 5 up to 15 years after randomization.
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.
From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spotlight Medical

Collaborators

Austrian Breast & Colorectal Cancer Study Group

Investigators

  • Study Chair: Michael Gnant, Univ.-Prof. Dr., Medical University of Vienna
  • Principal Investigator: Martin Filipits, Assoc.Prof.Univ.-Doz.Mag.Dr., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG TR Spotlight

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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