Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer (NCT04030507) | Clinical Trial Compass
RecruitingNot Applicable
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
United States214 participantsStarted 2019-07-26
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* Participants must be willing to undergo study procedures.
* The effects of gadolinium / other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physici…
What they're measuring
1
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
Timeframe: 12 Months
2
Incidence of Symptomatic Brain Metastases
Timeframe: Through study completion, an average of 1 year
3
Incidence of Brain Metastases
Timeframe: Through study completion, an average of 1 year