Study of Screening Brain MRIs in Stage IV Breast Cancer
- Conditions
- HER2-positive Breast CancerHormone Receptor-positive Breast CancerTriple Negative Breast Cancer
- Interventions
- Diagnostic Test: Magnetic Resonance Imaging
- Registration Number
- NCT05115474
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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
- Age ≥ 18
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with TNBC (triple negative breast cancer) Magnetic Resonance Imaging Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner. Participants with Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer Magnetic Resonance Imaging Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner. Participants with Hormone Receptor (HR) +Breast Cancer Magnetic Resonance Imaging Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
- Primary Outcome Measures
Name Time Method Rate of Brain Metastasis up to 6 months Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
- Secondary Outcome Measures
Name Time Method Number of Brain Metastases Baseline Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images.
Brain Metastasis Specific Survival Up to 6 months Brain metastasis specific survival following brain metastasis by breast cancer subtype
Overall Survival Up to 6 months Overall Survival (OS) will be measured from the initial on study date to the recorded date of death.
Rate of Asymptomatic Leptomeningeal Disease Baseline and at up to 6 months Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images.
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation Up to 6 months Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type.
Trial Locations
- Locations (2)
Morton Plant Mease- Baycare
🇺🇸Clearwater, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States