NCT03617341

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer With HER2 Positive
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-02
• Primary completion: 2021-07-30
• Completion: 2023-06-03
• First posted: 2018-08-06
• Last updated: 2020-10-27

Locations

1 site across 1 country: South Korea