Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
NCT ID: NCT03617341
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-10-02
2023-06-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Brain MRI
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.
Interventions
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Brain MRI
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2018-0254
Identifier Type: -
Identifier Source: org_study_id