HER2-positive Breast CancerNCT06330012
The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
A study testing GeoMx data analysis with clinical outcome in people with HER2-positive Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- GeoMx data analysis with clinical outcome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2024to 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HER2 positive breast cancer
- Stage IV disease
- Treated with T-Dxd
- Available FFPE samples
Who cannot join
- TNBC breast cancer
- Hormone receptor positive breast cancer
- Non-available FFPE samples
- Treated except T-Dxd
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, 82-2-3410-3459, jyeon25@skku.edu
MIRYOUNG HONG, 82-2-2148-7147, ring7629@naver.com
About this study
Official title: Spatial Transcriptomic Approach for Revealing the Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- GeoMx data analysis with clinical outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeoMx data analysis with clinical outcomeDiagnostic test
- List of HER2 positive breast cancer
- Stage IV disease
- Treated with T-Dxd
- Available FFPE samples
- Prepare tissue for digital spatial proteomics
- FFPE/H\&E slide
- Region of Interest(ROI) check
- Make a Tissue microarray
- Prepare special slide for GeoMx
- GeoMx data analysis with clinical outcome
| Study group | Role | What they receive |
|---|---|---|
| Spatial transcriptomic approch | Experimental | Spatial transcriptomic approch for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients. Receives: Diagnostic Test: GeoMx data analysis with clinical outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial transcriptomic analysis
Protein expression and relationship protein-protein in HER2 positive breast cancer tumor cells and tumor microenvironment.
Measured: Before chemotherapy, curative surgery
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 start18 Mar 2024 (estimated)
- Primary completion15 Jan 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 HER2-positive 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
- 50 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
- NCT06330012
- Sponsor's protocol ID
- GeoMx_Breast
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 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
- Spatial Transcriptomic Approach for Revealing the Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT06330012
- Acronym / sponsor ID
- GeoMx_Breast
- Conditions
- HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Mar 2024 (estimated)
- Primary completion
- 15 Jan 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 spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spatial transcriptomic approch | Experimental | Diagnostic Test: GeoMx data analysis with clinical outcomeSpatial transcriptomic approch for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- HER2 positive breast cancer
- Stage IV disease
- Treated with T-Dxd
- Available FFPE samples
Key exclusion criteria (4 listed)
- TNBC breast cancer
- Hormone receptor positive breast cancer
- Non-available FFPE samples
- Treated except T-Dxd
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 |
|---|---|---|
| GeoMx data analysis with clinical outcome1. List of HER2 positive breast cancer * Stage IV disease * Treated with T-Dxd * Available FFPE samples 2. Prepare tissue for digital spatial proteomics * FFPE/H\&E slide * Region of Interest(ROI) check * Make a Tissue microarray * Prepare special slide for GeoMx 3. GeoMx data analysis with clinical outcome | Diagnostic test | Spatial transcriptomic approch |
Primary outcome
Spatial transcriptomic analysis
Time frame: Before chemotherapy, curative surgery
Protein expression and relationship protein-protein in HER2 positive breast cancer tumor cells and tumor microenvironment.
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 GeoMx data analysis with clinical outcome in people with HER2-positive Breast Cancer, 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 4 inclusion and 4 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?
Spatial transcriptomic analysis (time frame: Before chemotherapy, curative surgery). 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.