Study of Screening Brain MRIs in Stage IV Breast Cancer

Study Overview
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Brief Summary
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The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Official Title
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Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

Conditions
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Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients Age ≥ 18 Life expectancy ≥ 6 months Eastern Cooperative Oncology Group performance status 0 to 2 Patients must be able to understand and the willingness to sign an informed consent for study procedures Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: Prior diagnosis or treatment of brain metastases or leptomeningeal disease Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment Indications warranting brain MRI for other neurologic conditions at time of study entry Contraindication towards MRI imaging with contrast Chronic kidney disease stage IV or V or end stage renal disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with TNBC (triple negative breast cancer)<br>Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner. | Diagnostic Test: Magnetic Resonance Imaging<br>* Participants will undergo MRI imaging with and without contrast.<br>* Other names: MRI;|
| Participants with Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer<br>Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner. | Diagnostic Test: Magnetic Resonance Imaging<br>* Participants will undergo MRI imaging with and without contrast.<br>* Other names: MRI;|
| Participants with Hormone Receptor (HR) +Breast Cancer<br>Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner. | Diagnostic Test: Magnetic Resonance Imaging<br>* Participants will undergo MRI imaging with and without contrast.<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Brain Metastasis | Rate of brain metastasis by breast cancer subtype at baseline using MRI images. | at Baseline | 
| Rate of Brain Metastasis | Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Asymptomatic Leptomeningeal Disease | Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images. | Baseline and at up to 6 months | 
| Number of Brain Metastases | Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images. | Baseline | 
| Overall Survival | Overall Survival (OS) will be measured from the initial on study date to the recorded date of death. | Up to 6 months | 
| Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation | Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type. | Up to 6 months | 
| Brain Metastasis Specific Survival | Brain metastasis specific survival following brain metastasis by breast cancer subtype | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage IV Breast Cancer