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Screening MRI for Brain Metastases in Breast Cancer

This study is looking at whether using magnetic resonance imaging (MRI) of the brain can help find breast cancer that has spread to the brain (brain metastases) earlier. You might be able to join if you have breast cancer, including HER2-positive, triple-negative, hormone receptor-positive, or inflammatory breast cancer. Researchers want to see if screening MRIs improve your quality of life and reduce how often symptomatic brain metastases occur over about one year. The study is a Phase II trial, meaning it's testing the safety and effectiveness of this screening method. It aims to enroll 214 participants.

Study design
This is a Phase II interventional study with 214 planned participants. Some participants will be randomized to receive screening MRI or no screening MRI, while others will be in single-arm groups receiving screening MRI.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your neurologic quality of life will be measured at 12 months, and the incidence of brain metastases will be tracked through study completion, an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04030507

Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Recruiting
NAAges 18+InterventionalScreening
Brigham and Women's Hospital
~214 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
Measured over 12 Months
+2 more outcomes measured

Conditions

Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Cancer
Hormone Receptor Positive Malignant Neoplasm of Breast
Inflammatory Breast Cancer
Metastatic Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Ayal Aizer, MD, MHS · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Ayal Aizer, MD, MHS
[email protected]
617-732-7560
Email the study team

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Eligibility criteria

Inclusion

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 physician immediately.
Participants must possess the ability to understand and the willingness to sign a written informed consent document.

Exclusion

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.
Patients with a prior diagnosis of brain metastases

What this trial measures

  • Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module12 Months

    For patients with HR+/HER2- or HER2+ metastatic breast cancer

  • Incidence of Symptomatic Brain MetastasesThrough study completion, an average of 1 year

    For patients with triple negative metastatic breast cancer

  • Incidence of Brain MetastasesThrough study completion, an average of 1 year

    For patients with inflammatory breast cancer managed with curative intent