This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease. In this research study, the investigators are utilizing screening MRIs of the brain to evaluate breast cancer patients for metastases to the brain. The investigators hope to understand whether screening MRIs of the brain can be implemented into the standard of care to earlier detect brain metastases in a population where screening MRIs of the brain are not currently recommended or systematically performed. This trial will contain 4 cohorts: 1\. Those with triple negative breast cancer (TNBC) will undergo screening MRI of the brain as part of a single arm, non-comparative study 2+3. Those with hormone receptor positive/(human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) and HER2 positive (HER2+) subtypes will be randomized to receipt of screening MRI of the brain or no screening MRI of the brain to definitively test the value of MRI screening. 4\. Patients with inflammatory breast cancer being treated with curative intent will undergo screening MRI of the brain as part of a single arm, non-comparative study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
214
MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGNeurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
For patients with HR+/HER2- or HER2+ metastatic breast cancer
Time frame: 12 Months
Incidence of Symptomatic Brain Metastases
For patients with triple negative metastatic breast cancer
Time frame: Through study completion, an average of 1 year
Incidence of Brain Metastases
For patients with inflammatory breast cancer managed with curative intent
Time frame: Through study completion, an average of 1 year
Number of brain metastases
Time frame: Through study completion, an average of 1 year
Size of brain metastases
Time frame: Through study completion, an average of 1 year
Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain
Time frame: Through study completion, an average of 1 year
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
Time frame: Through study completion, an average of 1 year
Radiographic appearance of brain metastases
Time frame: Through study completion, an average of 1 year
Development of symptomatic brain metastases based on review of medical notes / history
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Time frame: Through study completion, an average of 1 year
Neurologic death
Time frame: Through study completion, an average of 1 year
All-cause mortality
Time frame: Through study completion, an average of 1 year
Development of seizures based on review of medical notes / history
Time frame: Through study completion, an average of 1 year
Receipt of whole brain radiation due to brain metastases
Time frame: Through study completion, an average of 1 year
Receipt of neurosurgical resection due to brain metastases
Time frame: Through study completion, an average of 1 year
Quality of life assessment via EuroQol Group 5D Instrument
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Hopkins Verbal Learning Test Instrument
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Trail Making Test Instrument
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Controlled Oral Word Association Test
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Mini-Mental Status Exam Instrument
Time frame: Through study completion, an average of 1 year