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AI reads tumor slides to predict cancer return in early breast cancer

NCT ID NCT07541703

Diagnosis Sponsor: Spotlight Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing an artificial intelligence (AI) tool that analyzes digitized images of tumor tissue from 2,200 women with ER-positive, HER2-negative early breast cancer. The AI aims to predict the risk of cancer spreading to distant parts of the body. Researchers will compare the AI's predictions with actual patient outcomes to see how accurate it is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Artificial intelligence-based prognostic assay (diagnostic test)
What this could lead to
If successful, this AI tool could help doctors better predict which early breast cancer patients are at risk of distant recurrence, guiding treatment decisions.
What could go wrong
This is a retrospective observational study, not a prospective trial, so results may not apply to all patients. The AI tool's accuracy depends on the quality of stored tissue samples and data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Early breast cancer ER-positive HER2-negative breast cancer

Contacts and locations

Locations

  • Medical University of Vienna, Center of Cancer Research

    Vienna, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.