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

March 19, 2024 updated by: JI-YEON, KIM, Samsung Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spatial transcriptomic approch
Spatial transcriptomic approch for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.
Diagnostic test: GeoMx 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before chemotherapy, curative surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 18, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GeoMx_Breast

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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