Breast CancerNCT07541703
Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer
An observational study of Breast Cancer and Early Breast Cancer, run by Spotlight Medical at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Early Breast Cancer, ER-Positive HER2-Negative Breast Cancer
- What is being tested?
- Locked AI-based prognostic assay
- How many people
- 2,200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Locked AI-based prognostic assay
- Keywords
- digital pathology, artificial intelligence, prognostic assay, distant recurrence, ABCSG-8, ABCSG-16, endocrine therapy, whole slide imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Locked AI-based prognostic assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to distant recurrence
Association of the continuous assay score and predefined risk categories with time to distant recurrence.
Measured: From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.
Secondary outcomes (2)
Disease-free survival
Association of the continuous assay score and predefined risk categories with disease-free survival.
Measured: From ABCSG-8 randomization to first disease-free survival event, assessed up to 15 years.
Overall survival
Association of the continuous assay score and predefined risk categories with overall survival.
Measured: From ABCSG-8 randomization to death from any cause, assessed up to 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spotlight Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Austrian Breast & Colorectal Cancer Study Group
- Responsible party
- Sponsor
- Investigators
- Michael Gnant, Univ.-Prof. Dr., Study chair, Medical University of ViennaMartin Filipits, Assoc.Prof.Univ.-Doz.Mag.Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541703
- Sponsor's protocol ID
- ABCSG TR Spotlight
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 40845255Gnant 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.
PubMed 34320285Dubsky 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.
PubMed 22271481
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABCSG TR Spotlight: Validation of an Artificial Intelligence-based Prognostic Assay in ER+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT07541703
- Acronym / sponsor ID
- ABCSG TR Spotlight
- Keywords
- digital pathology, artificial intelligence, prognostic assay, distant recurrence, ABCSG-8, ABCSG-16, endocrine therapy, whole slide imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Spotlight MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Austrian Breast & Colorectal Cancer Study Group
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible ABCSG-8 cohort | – | Diagnostic Test: Locked AI-based prognostic assayEligible 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locked AI-based prognostic assayA 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. | Diagnostic test | Eligible ABCSG-8 cohort |
Primary outcome
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.
2 secondary outcomes
Disease-free survival
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 40845255Bidard 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.
- Background: PubMed 34320285Gnant 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.
- Background: PubMed 22271481Dubsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gnant, Univ.-Prof. Dr. study chair
Medical University of Vienna
Martin Filipits, Assoc.Prof.Univ.-Doz.Mag.Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Early Breast Cancer, run by Spotlight Medical at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to distant recurrence (time frame: From ABCSG-8 randomization to distant recurrence, assessed up to 15 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541703, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.