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Brain scans every 6 months could catch cancer spread earlier in stage IV breast cancer

NCT ID NCT07357298

Diagnosis Sponsor: H. Lee Moffitt Cancer Center and Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase III trial is testing whether routine brain MRIs every 6 months can detect brain metastases earlier in people with stage IV breast cancer who have no symptoms. Participants are randomly assigned to either scheduled scans or standard care (scans only if symptoms appear). The goal is to see if earlier detection changes treatment options and improves outcomes.

What this could mean

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

Active substance
Surveillance Brain MRI
What this could lead to
If successful, this could show that regular brain scans help catch metastases earlier, potentially reducing the need for whole-brain radiation and improving quality of life.
What could go wrong
This is a phase III trial, but it's still relatively small (156 participants) and focuses on detection, not a direct treatment. Earlier detection may not always improve survival or 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 156 people

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

Started

Feb 2026

Expected to finish

Feb 2030

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: * Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status * Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy as well. * HR+ will be defined as ER and/or PR \> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines41. Triple negative will be classified as ER and PR \<10% and HER2-. * Age ≥ 18 * Life expectancy ≥ 6 months * Eastern Cooperative Oncology Group performance status ≤ 2 * Patients must be able to understand and the willingness to sign an informed consent for study procedures * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Prior diagnosis or treatment of brain metastases or leptomeningeal disease * History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI * Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment * Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders) * Contraindication towards MRI with contrast * Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min)

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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

How to take part

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

  1. The places running it

    2 sites. 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

  • Baptist Health South Florida

    NOT_YET_RECRUITING

    Miami, Florida, 33176, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

More trials for these conditions

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