NCT07541703

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Mar 2028

Study Start

First participant enrolled

April 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 10, 2026

Last Update Submit

April 16, 2026

Conditions

Breast CancerEarly Breast CancerER-Positive HER2-Negative Breast Cancer

Keywords

digital pathologyartificial intelligenceprognostic assaydistant recurrenceABCSG-8ABCSG-16endocrine therapywhole slide imaging

Outcome Measures

Primary Outcomes (1)

  • Time to distant recurrence

    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 Outcomes (2)

  • Disease-free survival

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

  • Overall survival

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

Other Outcomes (3)

  • Early distant recurrence (0 to 5 years)

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

  • Late distant recurrence (>5 years, landmark analysis)

    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

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

Study Arms (1)

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

Interventions

Locked AI-based prognostic assayDIAGNOSTIC_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.

Eligible ABCSG-8 cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Center of Cancer Research

Vienna, Austria

Location

Related Publications (3)

  • Bidard FC, Gessain G, Bachelot T, Frechin L, Vincent-Salomon A, Drubay D, Lemonnier J, Walter T, Penault-Llorca F, Martin AL, Gaudin C, Bichat A, Sassi F, Berlemont S, Chavez-MacGregor M, Rugo HS, Badoual C, Pistilli B, Ribeiro J, Di Meglio A, Lacroix-Triki M, Vaz Luis I, Lerousseau M, Andre F. Identifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay. J Clin Oncol. 2025 Oct;43(28):3090-3101. doi: 10.1200/JCO-25-00742. Epub 2025 Aug 22.

    PMID: 40845255BACKGROUND

  • Gnant M, Fitzal F, Rinnerthaler G, Steger GG, Greil-Ressler S, Balic M, Heck D, Jakesz R, Thaler J, Egle D, Manfreda D, Bjelic-Radisic V, Wieder U, Singer CF, Melbinger-Zeinitzer E, Haslbauer F, Sevelda P, Trapl H, Wette V, Wimmer K, Gampenrieder SP, Bartsch R, Kacerovsky-Strobl S, Suppan C, Brunner C, Deutschmann C, Soelkner L, Fesl C, Greil R; Austrian Breast and Colorectal Cancer Study Group. Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer. N Engl J Med. 2021 Jul 29;385(5):395-405. doi: 10.1056/NEJMoa2104162.

    PMID: 34320285BACKGROUND

  • Dubsky PC, Jakesz R, Mlineritsch B, Postlberger S, Samonigg H, Kwasny W, Tausch C, Stoger H, Haider K, Fitzal F, Singer CF, Stierer M, Sevelda P, Luschin-Ebengreuth G, Taucher S, Rudas M, Bartsch R, Steger GG, Greil R, Filipcic L, Gnant M. Tamoxifen and anastrozole as a sequencing strategy: a randomized controlled trial in postmenopausal patients with endocrine-responsive early breast cancer from the Austrian Breast and Colorectal Cancer Study Group. J Clin Oncol. 2012 Mar 1;30(7):722-8. doi: 10.1200/JCO.2011.36.8993. Epub 2012 Jan 23.

    PMID: 22271481BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archived pseudonymized primary breast tumor material from ABCSG-8 used to prepare H\&E-stained slides for digitization. No additional biospecimens are collected for this study.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Gnant, Univ.-Prof. Dr.

    Medical University of Vienna

    STUDY CHAIR

  • Martin Filipits, Assoc.Prof.Univ.-Doz.Mag.Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 21, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)