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

  • STATUS
    Recruiting
  • End date
    Jun 3, 2023
  • participants needed
    200
  • sponsor
    Yonsei University
Updated on 26 January 2021
cancer
breast cancer
metastasis
HER2
brain metastases
triple negative breast cancer
stage iv breast cancer
erbb2

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.

Details
Condition Breast Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Metastatic Breast Cancer With HER2 Positive
Treatment Brain MRI
Clinical Study IdentifierNCT03617341
SponsorYonsei University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note