NCT05115474 · H. Lee Moffitt Cancer Center and Research Institute
Study of Screening Brain MRIs in Stage IV Breast Cancer
What this study is about
The study is a single treatment group$1, nonrandomized phase II forward-looking study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Primary outcome measures
Rate of Brain Metastasis
Time frame: at Baseline
Rate of brain metastasis by breast cancer subtype at baseline using MRI images.
Rate of Brain Metastasis
Time frame: up to 6 months
Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
- Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients
- Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
- Life expectancy ≥ 6 months
- Eastern Cooperative Oncology Group performance status 0 to 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
- Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
- 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
- Contraindication towards MRI imaging with contrast
- Chronic kidney disease stage IV or V or end stage renal disease
Where
- Clearwater, Florida
- Tampa, Florida
Collaborators
Florida Breast Cancer Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations