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

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

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients over 19 years
Pathologically documented breast cancer that:
1. is unresectable or metastatic ;
2. 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

Arm && Interventions

Group	Intervention	Description
Brain MRI	Brain MRI	Regular brain MRI can detect early brain metastases in metastatic Breast cancer with high risk subgroups, such as HER2-positive and triple negative.

Primary Outcome Measures

Name	Time	Method
The incidence rates of brain metastases with high risk patients in metastatic breast cancer	5 years	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

Secondary Outcome Measures

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

Locations (1): Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of