CClinicalTrials.gg
RecruitingNCT06330012Updated Mar 26, 2024

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

An interventional study of GeoMx data analysis with clinical outcome in HER2-positive Breast Cancer, sponsored by Samsung Medical Center. Recruiting at 1 site in Korea, Republic of. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Sex
Female
01

Study summary

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

02

Conditions studied

  • HER2-positive Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • TNBC breast cancer
  • Hormone receptor positive breast cancer
  • Non-available FFPE samples
  • Treated except T-Dxd
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

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

06

What researchers measure

Primary outcomes

  1. Spatial transcriptomic analysis

    Protein expression and relationship protein-protein in HER2 positive breast cancer tumor cells and tumor microenvironment.

    Time frame: Before chemotherapy, curative surgery

07

Study locations

1 of 1 sites recruiting
  • Ji-Yeon Kim
    Seoul, 06351, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06330012
Lead sponsor
Samsung Medical Center
Responsible party
JI-YEON, KIM (Professor, Samsung Medical Center) — Principal investigator
First posted
Mar 26, 2024
Start date
Mar 18, 2024 (estimated)
Primary completion
Jan 15, 2025 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 26, 2024

Study contacts

Ji-Yeon Kim
Contact
jyeon25@skku.edu
82-2-3410-3459
MIRYOUNG HONG
Contact
ring7629@naver.com
82-2-2148-7147

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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