Brain MRI Surveillance for Stage IV Breast Cancer

Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer

Recruiting Phase 3 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Screening
Participants needed
156 (estimated)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Who this trial is looking for

This trial is looking for women with stage IV breast cancer who do not have symptoms affecting their brain. Participants will get brain MRI scans every 6 months to see if this helps find brain issues earlier.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with breast cancer.
  • I am at stage IV of the disease.
  • I am 18 years old or older.
  • I expect to live at least 6 more months.
  • I can understand and sign consent forms.
  • I agree to follow all study procedures.
  • I have ER/PR/HER2 status documented.

You may not be able to join if

  • I have had brain metastases or leptomeningeal disease before.
  • I have a history of another serious cancer that needs treatment.
  • I have symptoms that require a standard brain MRI.
  • I have conditions like multiple sclerosis or stroke that need a brain MRI.
  • I cannot have an MRI with contrast.
  • I have severe kidney disease or am in end stage renal disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or sta…
Trial Locations
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Eligibility Criteria
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 th…
Contacts

Rheese McNab

813-745-1780

Rheese.McNab@moffitt.org

CONTACT