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

NCT ID: NCT06330012

Condition: HER2-positive Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: GeoMx data analysis with clinical outcome
Description: 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
Arm group label: Spatial transcriptomic approch

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

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Ji-Yeon Kim

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Ji-Yeon Kim

Phone: 82-2-3410-3459
Email: jyeon25@skku.edu

Contact backup:
Last name: MIRYOUNG HONG

Phone: 82-2-2148-7147
Email: ring7629@naver.com

Start date: March 18, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Samsung Medical Center
Agency class: Other

Source: Samsung Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06330012

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