Clinical trial · Observational
Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer
ABCSG TR Spotlight: Validation of an Artificial Intelligence-based Prognostic Assay in ER+/HER2- Breast Cancer
NCT07541703CI-TRIAL-00108935active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early Breast Cancer | — | UNRESOLVED | — |
| ER-Positive HER2-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Locked AI-based prognostic assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Eligible ABCSG-8 cohort
- description
- 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.
- interventionNames
- Diagnostic Test: Locked AI-based prognostic assay
Primary outcomes (1)
- measure
- Time to distant recurrence
- timeFrame
- From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.
- description
- Association of the continuous assay score and predefined risk categories with time to distant recurrence.
Secondary outcomes (2)
- measure
- Disease-free survival
- timeFrame
- From ABCSG-8 randomization to first disease-free survival event, assessed up to 15 years.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDBidard 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 40845255
- BACKGROUNDGnant 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 34320285
- BACKGROUNDDubsky 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 22271481