Actively Recruiting

Age: 18Years +
All Genders
NCT05115474

Study of Screening Brain MRIs in Stage IV Breast Cancer

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-09

170

Participants Needed

2

Research Sites

249 weeks

Total Duration

On this page

Sponsors

H

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

F

Florida Breast Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

CONDITIONS

Official Title

Study of Screening Brain MRIs in Stage IV Breast Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic diagnosis of breast cancer with documented ER/PR/HER2 status
  • Radiographic evidence of stage IV extracranial disease progressed past first-line therapy in HR+/HER2- patients
  • Radiographic evidence of stage IV extracranial disease in triple negative and HER2+ patients
  • Age 18 years or older
  • Life expectancy of at least 6 months
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Ability to understand and willingness to sign informed consent
  • Willingness to comply with all study procedures and availability for study duration
Not Eligible

You will not qualify if you...

  • Prior diagnosis or treatment of brain metastases or leptomeningeal disease
  • History of non-breast cancer malignancies with disease activity within past 2 years
  • Neurologic symptoms requiring standard brain MRI screening at enrollment
  • Conditions requiring brain MRI for other neurologic reasons at study entry
  • Contraindications to MRI imaging with contrast
  • Chronic kidney disease stage IV or V or end-stage renal disease

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Morton Plant Mease- Baycare

Clearwater, Florida, United States, 33756

Actively Recruiting

2

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Active, Not Recruiting

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Research Team

R

Robin Dowell

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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