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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • MRI

    Device

    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).

Treatment groups

214 Participants
are divided into 4 treatment groups
Group A: Inflammatory Breast Cancer Managed with Curative IntentExperimental treatment 1 intervention
Group B: HR+ or HER2+ Metastatic Breast Cancer - Screening ArmExperimental treatment 1 intervention
Group C: HR+ or HER2+ Metastatic Breast Cancer - No Screening ArmNo intervention 0 interventions
Group D: Triple Negative Breast CancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 Months
2

Incidence of Symptomatic Brain Metastases

For patients with triple negative metastatic breast cancer

Time frame
Through study completion, an average of 1 year
3

Incidence of Brain Metastases

For patients with inflammatory breast cancer managed with curative intent

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Number of brain metastases

Time frame
Through study completion, an average of 1 year
2

Size of brain metastases

Time frame
Through study completion, an average of 1 year
3

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
4

Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Conquer Cancer Foundation

Collaborator

Dana-Farber Cancer Institute

Collaborator