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

NCT ID: NCT06330012

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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Conditions

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HER2-positive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Spatial transcriptomic approch

Spatial transcriptomic approch for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.

Group Type EXPERIMENTAL

GeoMx data analysis with clinical outcome

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JI-YEON, KIM

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ji-Yeon Kim

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ji-Yeon Kim

Role: CONTACT

82-2-3410-3459

MIRYOUNG HONG

Role: CONTACT

82-2-2148-7147

Facility Contacts

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Ji-Yeon Kim

Role: primary

82-2-3410-3459

MIRYOUNG HONG

Role: backup

82-2-2148-7147

Other Identifiers

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GeoMx_Breast

Identifier Type: -

Identifier Source: org_study_id

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