Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer

Study Overview
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Brief Summary
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In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

Detailed Description
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It is well known that HER2-receptor positive and triple negative metastatic breast cancer (MBC) have poor prognosis than hormone receptor positive metastatic breast cancer. However, as new therapies such as trastuzumab and pertuzumab are introduced, overall survival was extended in patients with metastatic breast cancer compared with the previous 10 years. As a result, the number of breast cancer patients with brain metastases has increased, the demand for treatments of brain metastases is increasing. The incidence of brain metastases in MBC has been reported to be 7.6% and 10.8% in luminal A / B, respectively. However, HER2-positive and triple negative breast cancer with the incidence of more than 30% of brain metastases were at high risk group of brain metastases. In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

Official Title
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Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer With HER2 Positive, Triple Negative Breast Cancer

Intervention / Treatment
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* Procedure: Brain MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 19 years Pathologically documented breast cancer that: is unresectable or metastatic ; has confirmed HER2 positive expression according to American Society of Clinical Oncology- College of American Pathologists (ASCO-CAP) guidelines or triple negative breast cancer No prior systemic palliative treatment of metastatic breast cancer Must have provided informed consent for study participation before performance of any study-specific procedures or tests Exclusion Criteria: History of prior treatments about brain metastases or leptomeningeal metastases Symptomatic brain metastases at screening period Has received more than second-line systemic treatments (including endocrine therapy) For subjects who have difficulty lying down or who have claustrophobia, they can undergo sedation during brain MRI History of hypersensitivity reaction to contrast or drug allergic reaction Patients who inserted metallic prosthesis (pacemaker, denture, hearing aid, aneurysm clip, metallic material of eyeball, artificial joint, insulin pump, chemo-port, temporary tissue expander for breast reconstruction, etc) can be conducted after consultation with investigator before MRI. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Social, familial, or geographical factors that would interfere with study participation or follow-up

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Brain MRI<br>Regular brain MRI can detect early brain metastases in metastatic Breast cancer with high risk subgroups, such as HER2-positive and triple negative. | Procedure: Brain MRI<br>* Brain MRI will be taken at the time of initial diagnosis, first- and second-line treatment failure. Therefore, the investigators expect that early detection of brain metastases before the onset of symptoms will affect the overall prognosis of MBC patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rates of brain metastases with high risk patients in metastatic breast cancer | The incidence rates of brain metastases with high risk patients in metastatic breast cancer at initial diagnosis and failure of first- and second-line treatments confirmed by brain MRI | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI | To evaluate the incidence rate of brain oligometastsais (≤ 4) confirmed by brain MRI | 5 years | 
| Intracranial progression free survival(PFS) after treatment of brain metastases | To evaluate intracranial progression free survival(PFS) after treatment of brain metastases | 5 years | 
| The overall survival (OS) after diagnosis to brain metastases | To evaluate the overall survival (OS) after diagnosis to brain metastases | 5 years | 
| The period from diagnosis to treatment of brain metastases | To evaluate the period from diagnosis to treatment of brain metastases | 5 years | 
| The cognitive impairment assessment after brain metastases | To evaluate the cognitive impairment assessment after brain metastases | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, brain metastases, screening, brain MRI