Breast CancerNCT06330870
Brain Metastasis Development Mechanism in BCBM Patients
A study testing WGS/TME evaluation in people with Breast Cancer and Brain Metastasis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Brain Metastasis
- What is being tested?
- WGS/TME evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer
- Brain metastasis curative surgery patient
Who cannot join
- Gamma Knife surgery patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ji-Yeon Kim
Seoul, 06351
Ji-Yeon Kim
About this study
Official title: Evaluation of Brain Metastasis Development Mechanism in Patients With Breast Cancer With Brain Metastasis(BCBM)
This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis
- Conditions
- Breast Cancer, Brain Metastasis
- Being tested
- WGS/TME evaluation
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGS/TME evaluationProcedure or surgery
WGS/TME evaluation with blood and brain metastasis tissue during brain metastasis curative surgery
| Study group | Role | What they receive |
|---|---|---|
| WGS/TME evaluation | Experimental | This is not intervention clinical trial design. We explore whole genome sequencing and tumor microenvironment evaluation for brain metastasis specimen in breast cancer patients. Receives: Procedure: WGS/TME evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial disease free survival
Time to new brain metastasis or brain metastasis progression from the brain surgery
Measured: Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start6 Apr 2023
- Primary completion5 Feb 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JI-YEON, KIM, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330870
- Sponsor's protocol ID
- BCBM_Breast
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Metastasis Development Mechanism in Patients With Breast Cancer With Brain Metastasis(BCBM)
- ClinicalTrials.gov ID
- NCT06330870
- Acronym / sponsor ID
- BCBM_Breast
- Conditions
- Breast Cancer, Brain Metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 5 Feb 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Mar 2024 (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.
This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WGS/TME evaluation | Experimental | Procedure: WGS/TME evaluationThis is not intervention clinical trial design. We explore whole genome sequencing and tumor microenvironment evaluation for brain metastasis specimen in breast cancer patients. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer
- Brain metastasis curative surgery patient
Key exclusion criteria (1 listed)
- Gamma Knife surgery patient
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 |
|---|---|---|
| WGS/TME evaluationWGS/TME evaluation with blood and brain metastasis tissue during brain metastasis curative surgery | Procedure or surgery | WGS/TME evaluation |
Primary outcome
Intracranial disease free survival
Time frame: Months
Time to new brain metastasis or brain metastasis progression from the brain surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WGS/TME evaluation in people with Breast Cancer and Brain Metastasis, run by Samsung Medical Center 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji-Yeon Kim (82-2-3410-3459, jyeon25@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial disease free survival (time frame: Months). 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 26 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.