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NCT06330012 Clinical Trial

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

HER2-positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06330012
Other study ID # GeoMx_Breast
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 18, 2024
Est. completion date December 31, 2027

Study information
Verified date March 2024
Source Samsung Medical Center
Contact Ji-Yeon Kim
Phone 82-2-3410-3459
Email jyeon25@skku.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2027
Est. primary completion date January 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• GeoMx data analysis with clinical outcome
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

Locations
Country Name City State
Korea, Republic of Ji-Yeon Kim Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spatial transcriptomic analysis Protein expression and relationship protein-protein in HER2 positive breast cancer tumor cells and tumor microenvironment. Before chemotherapy, curative surgery
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