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

Triple Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03617341
• Other study ID #: 4-2018-0254
• Status: Recruiting
• Start date: October 2, 2018
• Est. completion date: June 3, 2023

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: Joohyuk Sohn, MD, Ph.D
• Phone: 82-2-2228-8130
• Email: oncosohn[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 3, 2023
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer With HER2 Positive
• Neoplasm Metastasis
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cancer Center, Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Intracranial progression free survival(PFS) after treatment of brain metastases	To evaluate intracranial progression free survival(PFS) after treatment of brain metastases	5 years
Secondary	The overall survival (OS) after diagnosis to brain metastases	To evaluate the overall survival (OS) after diagnosis to brain metastases	5 years
Secondary	The period from diagnosis to treatment of brain metastases	To evaluate the period from diagnosis to treatment of brain metastases	5 years
Secondary	The cognitive impairment assessment after brain metastases	To evaluate the cognitive impairment assessment after brain metastases	5 years