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

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 Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer; Metastatic Breast Cancer With HER2 Positive
• Intervention / Treatment: Procedure: Brain MRI

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Joohyuk Sohn, MD, Ph.D; Phone Number: 82-2-2228-8130; Email: oncosohn@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
    • Contact: Joo Hyuk Sohn, MD, PhD; Phone Number: 82-2-2228-8130; Email: oncosohn@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were initial diagnosed with HER2-positive, triple negative metastatic breast cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rates of brain metastases with high risk patients in metastatic breast cancer	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	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): June 3, 2023

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer; screening; brain metastases; brain MRI
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 4-2018-0254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No