NCT06330012

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Mar 2024Dec 2027

Study Start

First participant enrolled

March 18, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 19, 2024

Last Update Submit

March 19, 2024

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Spatial transcriptomic analysis

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

    Before chemotherapy, curative surgery

Study Arms (1)

Spatial transcriptomic approch

EXPERIMENTAL

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

GeoMx data analysis with clinical outcomeDIAGNOSTIC_TEST

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

Spatial transcriptomic approch

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji-Yeon Kim

Seoul, 06351, South Korea

RECRUITING

Central Study Contacts

Ji-Yeon Kim

CONTACT

82-2-3410-3459jyeon25@skku.edu

MIRYOUNG HONG

CONTACT

82-2-2148-7147ring7629@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

March 18, 2024

Primary Completion

January 15, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)