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

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ClinicalTrials.gov Identifier: NCT03617341
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Metastatic Breast Cancer With HER2 Positive Triple Negative Breast Cancer 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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : June 3, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. The incidence rates of brain metastases with high risk patients in metastatic breast cancer [ Time Frame: 5 years ]
    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


Secondary Outcome Measures :
  1. The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI [ Time Frame: 5 years ]
    To evaluate the incidence rate of brain oligometastsais (≤ 4) confirmed by brain MRI

  2. Intracranial progression free survival(PFS) after treatment of brain metastases [ Time Frame: 5 years ]
    To evaluate intracranial progression free survival(PFS) after treatment of brain metastases

  3. The overall survival (OS) after diagnosis to brain metastases [ Time Frame: 5 years ]
    To evaluate the overall survival (OS) after diagnosis to brain metastases

  4. The period from diagnosis to treatment of brain metastases [ Time Frame: 5 years ]
    To evaluate the period from diagnosis to treatment of brain metastases

  5. The cognitive impairment assessment after brain metastases [ Time Frame: 5 years ]
    To evaluate the cognitive impairment assessment after brain metastases



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were initial diagnosed with HER2-positive, triple negative metastatic breast cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617341


Contacts
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Contact: Joohyuk Sohn, MD, Ph.D 82-2-2228-8130 oncosohn@yuhs.ac

Locations
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Korea, Republic of
Yonsei Cancer Center, Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Joo Hyuk Sohn, MD, PhD    82-2-2228-8130    oncosohn@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03617341     History of Changes
Other Study ID Numbers: 4-2018-0254
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
Breast cancer
brain metastases
screening
brain MRI

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes