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Can a simple test predict breast cancer brain spread?

NCT ID NCT07447544

Knowledge-focused Sponsor: Institute of Oncology Ljubljana 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study examines stored tumor tissue and blood samples from 22 women with early breast cancer to find genetic or chemical markers that might predict whether the cancer will spread to the brain. Researchers will compare women whose cancer did spread to the brain with those whose did not. The goal is to identify warning signs that could lead to earlier detection, not to test a new treatment.

What this could mean

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

What this could lead to
If successful, this could lead to a blood or tissue test that identifies breast cancer patients at higher risk for brain metastases, allowing closer monitoring.
What could go wrong
This is a very small, observational study (22 people) that only looks for patterns. It does not test any treatment, so any potential test would need much larger studies to confirm.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

22 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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 aged 18 years or older. * Diagnosis of early-stage breast cancer. * Availability of archived primary tumor tissue suitable for mRNA analysis. * Availability of serum sample suitable for chemokine analysis. * Patients included in the AKRA cohort with documented follow-up data. * Patients with confirmed CNS metastases during follow-up (CNS metastases group) or matched controls without CNS metastases (control group). Exclusion Criteria: * Male breast cancer patients. * Lack of sufficient primary tumor tissue for mRNA analysis. * Lack of available serum sample for chemokine analysis. * Incomplete clinical follow-up data preventing classification of CNS metastasis status.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer Central nervous system metastases

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

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