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MRI Screening for Brain Metastases in Breast Cancer

N/A

Recruiting

Led By Ayal Aizer, MD, MHS

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be age 18 years or older.

Be older than 18 years old

Must not have

Patients with a prior diagnosis of brain metastases

Participants who have chronic kidney disease stage IV-V or end stage renal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if MRI can find brain metastases in people with breast cancer.

Who is the study for?

This trial is for adults over 18 with confirmed breast cancer, either starting first/second-line chemo for metastatic disease or managing inflammatory breast cancer. They must expect to live more than 12 weeks and agree to use birth control. It's not for those with MRI contraindications, severe kidney disease, gadolinium allergies, or existing brain metastases.

What is being tested?

The study tests if MRI can effectively screen for the spread of breast cancer to the brain in patients undergoing certain treatments. The goal is to assess how useful MRI scans are in detecting these brain metastases early on.

What are the potential side effects?

MRI itself typically doesn't cause side effects; however, some may experience discomfort from lying still during the scan or claustrophobia. There's also a small risk of an allergic reaction to gadolinium contrast used during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with brain metastases before.

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I have advanced or end-stage kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Brain Metastases

Incidence of Symptomatic Brain Metastases

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Triple Negative Breast CancerExperimental Treatment1 Intervention

* An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry

Group II: Inflammatory Breast Cancer Managed with Curative IntentExperimental Treatment1 Intervention

* Patients will receive an initial screening magnetic resonance imaging (MRI) of the brain * If no evidence of intracranial involvement is identified, additional screening MRIs of the brain every six months for two years and at initial systemic progression.

Group III: HR+ or HER2+ Metastatic Breast Cancer - Screening ArmExperimental Treatment1 Intervention

* An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry

Group IV: HR+ or HER2+ Metastatic Breast Cancer - No Screening ArmActive Control1 Intervention

No initial MRI screening will be conducted

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~2810

0 / 3Eligibility criteria met