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

NCT03617341 | Unknown

• 1 other identifier: 4-2018-0254
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer With HER2 Positive; Triple Negative Breast Cancer

Keywords

Breast cancer; brain metastases; screening; brain MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI

  5 years

• Intracranial progression free survival(PFS) after treatment of brain metastases

  5 years

• The overall survival (OS) after diagnosis to brain metastases

  5 years

• The period from diagnosis to treatment of brain metastases

  5 years

• The cognitive impairment assessment after brain metastases

  5 years

Study Arms (1)

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

Interventions

Brain MRI PROCEDURE

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.

Brain MRI

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients over 19 years
• Pathologically documented breast cancer that:
• is unresectable or metastatic ;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center, Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Joohyuk Sohn, MD, Ph.D

CONTACT

82-2-2228-8130; oncosohn@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 6, 2018
• Study Start: October 2, 2018
• Primary Completion: July 30, 2021
• Study Completion: June 3, 2023
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

KR (1)