About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and/or study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.
Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic/recurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.
Participants must be age 18 years or older.
Participants must have a life expectancy of greater than 12 weeks.
Disqualifiers
Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).
Participants who have chronic kidney disease stage IV-V or end stage renal disease.
Participants with a history of anaphylactic reactions to gadolinium.
Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
Trial design
Parallel
Treatments tested in this trial
MRI
DeviceMRI (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).
Treatment groups
Trial outcomes
Primary outcomes
Neurologic 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
Incidence of Symptomatic Brain Metastases
For patients with triple negative metastatic breast cancer
Incidence of Brain Metastases
For patients with inflammatory breast cancer managed with curative intent
Secondary outcomes
Number of brain metastases
Size of brain metastases
Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
Sponsors and contacts
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Brigham and Women's Hospital
Lead sponsor
Conquer Cancer Foundation
Collaborator
Dana-Farber Cancer Institute
Collaborator