Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03617341|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment|
|Metastatic Breast Cancer With HER2 Positive Triple Negative Breast Cancer||Procedure: Brain MRI|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||June 3, 2023|
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
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.
- The incidence rates of brain metastases with high risk patients in metastatic breast cancer [ Time Frame: 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
- The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI [ Time Frame: 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 [ Time Frame: 5 years ]To evaluate intracranial progression free survival(PFS) after treatment of brain metastases
- The overall survival (OS) after diagnosis to brain metastases [ Time Frame: 5 years ]To evaluate the overall survival (OS) after diagnosis to brain metastases
- The period from diagnosis to treatment of brain metastases [ Time Frame: 5 years ]To evaluate the period from diagnosis to treatment of brain metastases
- The cognitive impairment assessment after brain metastases [ Time Frame: 5 years ]To evaluate the cognitive impairment assessment after brain metastases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617341
|Contact: Joohyuk Sohn, MD, Ph.Demail@example.com|
|Korea, Republic of|
|Yonsei Cancer Center, Severance Hospital, Yonsei University Health System||Not yet recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Joo Hyuk Sohn, MD, PhD 82-2-2228-8130 firstname.lastname@example.org|