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NCT Number: NCT06330012

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.

Recruiting

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GeoMx data analysis with clinical outcome

Diagnostic 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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ji-Yeon Kim

CONTACT

[email protected]

82-2-3410-3459

MIRYOUNG HONG

CONTACT

[email protected]

82-2-2148-7147

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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