Metastatic Breast Cancer With HER2 PositiveNCT03617341
Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer With HER2 Positive and Triple Negative Breast Cancer, run by Yonsei University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Breast Cancer With HER2 Positive, Triple Negative Breast Cancer
- What is being tested?
- Brain MRI
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2018to 3 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were initial diagnosed with HER2-positive, triple negative metastatic breast cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Seoul, 03722
Joo Hyuk Sohn, MD, PhD, 82-2-2228-8130, oncosohn@yuhs.ac
About this study
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.
Read the 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.
- Being tested
- Brain MRI
- Keywords
- Breast cancer, brain metastases, screening, brain MRI
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (5)
The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI
To evaluate the incidence rate of brain oligometastsais (≤ 4) confirmed by brain MRI
Measured: 5 years
Intracranial progression free survival(PFS) after treatment of brain metastases
To evaluate intracranial progression free survival(PFS) after treatment of brain metastases
Measured: 5 years
The overall survival (OS) after diagnosis to brain metastases
To evaluate the overall survival (OS) after diagnosis to brain metastases
Measured: 5 years
The period from diagnosis to treatment of brain metastases
To evaluate the period from diagnosis to treatment of brain metastases
Measured: 5 years
The cognitive impairment assessment after brain metastases
To evaluate the cognitive impairment assessment after brain metastases
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start2 Oct 2018
- Primary completion30 Jul 2021 (estimated)
- Study completion3 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer With HER2 PositiveStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617341
- Sponsor's protocol ID
- 4-2018-0254
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2018
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03617341
- Acronym / sponsor ID
- 4-2018-0254
- Keywords
- Breast cancer, brain metastases, screening, brain MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 3 Jun 2023 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain MRI | – | Procedure: Brain MRIRegular brain MRI can detect early brain metastases in metastatic Breast cancer with high risk subgroups, such as HER2-positive and triple negative. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were initial diagnosed with HER2-positive, triple negative metastatic breast cancer
Key inclusion criteria (6 listed)
- Patients over 19 years
- Pathologically documented breast cancer that:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIBrain 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. | Procedure or surgery | Brain MRI |
Primary outcome
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
5 secondary outcomes
The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI
Time frame: 5 years
Intracranial progression free survival(PFS) after treatment of brain metastases
Time frame: 5 years
The overall survival (OS) after diagnosis to brain metastases
Time frame: 5 years
The period from diagnosis to treatment of brain metastases
Time frame: 5 years
The cognitive impairment assessment after brain metastases
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer With HER2 Positive and Triple Negative Breast Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joohyuk Sohn, MD, Ph.D (82-2-2228-8130, oncosohn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rates of brain metastases with high risk patients in metastatic breast cancer (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.