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The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.

Spatial Transcriptomic Approach for Revealing the Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06330012
Enrollment
50
Registered
2024-03-26
Start date
2024-03-18
Completion date
2027-12-31
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Breast Cancer

Brief summary

This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.

Interventions

DIAGNOSTIC_TESTGeoMx data analysis with clinical outcome

1. 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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* HER2 positive breast cancer * Stage IV disease * Treated with T-Dxd * Available FFPE samples

Exclusion criteria

* TNBC breast cancer * Hormone receptor positive breast cancer * Non-available FFPE samples * Treated except T-Dxd

Design outcomes

Primary

MeasureTime frameDescription
Spatial transcriptomic analysisBefore chemotherapy, curative surgeryProtein expression and relationship protein-protein in HER2 positive breast cancer tumor cells and tumor microenvironment.

Countries

South Korea

Contacts

Primary ContactJi-Yeon Kim
jyeon25@skku.edu82-2-3410-3459
Backup ContactMIRYOUNG HONG
ring7629@naver.com82-2-2148-7147

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026