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Brain scan surveillance trial launches for HER2+ breast cancer patients

NCT ID NCT07503717

Knowledge-focused Sponsor: Royal College of Surgeons, Ireland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether it's possible to routinely scan the brains of people with HER2-positive metastatic breast cancer to find cancer spread early. About 69 participants will get a baseline brain MRI, and if no brain tumors are found, they'll be randomly assigned to either follow-up scans or standard care. The goal is to see if patients are willing to join and if early detection improves outcomes.

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

About 69 people

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

Started

Jun 2025

Expected to finish

Jun 2028

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

Anyone

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: * Age ≥18 years * Male or female * Histologically or cytologically confirmed HER2-positive breast cancer * Evidence of metastatic breast cancer * Estrogen receptor (ER) positive or negative disease permitted * Presence of visceral metastatic disease * Receiving active HER2-directed systemic therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Estimated life expectancy greater than 6 months * Ability to provide written informed consent * Willing and able to comply with study procedures and follow-up Exclusion Criteria: * Prior history of brain metastases * History or evidence of leptomeningeal carcinomatosis * Symptoms suggestive of brain metastases at screening * Bone-only metastatic disease * Inability to undergo MRI scanning * Known hypersensitivity or contraindication to MRI contrast agents that cannot - be managed per local standard of care * Significant medical condition or laboratory abnormality that, in the opinion of - the investigator, makes participation inappropriate Inability to provide informed consent * Deemed unsuitable for participation by the principal investigator due to clinical, mobility, or social circumstances

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer HER2-positive metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beaumont RCSI Cancer Centre

    RECRUITING

    Beaumont, Ireland

More trials for these conditions

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