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

Last updated: October 25, 2020
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT03617341
4-2018-0254
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ClinicalOncology- College of American Pathologists (ASCO-CAP) guidelines or triplenegative breast cancer
  • No prior systemic palliative treatment of metastatic breast cancer
  • Must have provided informed consent for study participation before performance of anystudy-specific procedures or tests

Exclusion

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 canundergo sedation during brain MRI
  • History of hypersensitivity reaction to contrast or drug allergic reaction
  • Patients who inserted metallic prosthesis (pacemaker, denture, hearing aid, aneurysmclip, metallic material of eyeball, artificial joint, insulin pump, chemo-port,temporary tissue expander for breast reconstruction, etc) can be conducted afterconsultation with investigator before MRI.
  • Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.
  • Social, familial, or geographical factors that would interfere with studyparticipation or follow-up

Study Design

Total Participants: 200
Study Start date:
October 02, 2018
Estimated Completion Date:
June 03, 2023

Study 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.

Connect with a study center

  • Yonsei Cancer Center, Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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