Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

NCT ID: NCT05910710

Last Updated: 2023-06-20

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

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-02

Study Completion Date

2025-12-31

Brief Summary

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It analyzes the Tumor microenvironment(TME) changes in non pathologic complete response(pCR) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer.

(Neoadjuvant Weekly paclitaxel, Carboplatin +- Pembrolizumab followed by Doxorubicin, Cyclophosphamide +- Pembrolizumab regimen)

Detailed Description

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Conditions

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Triple Negative Breast Cancer Neoadjuvant Chemotherapy Pembrolizumab Tumor Microenvironment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects administered Neoadjuvant Pembrolizumab

Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab

Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)

Intervention Type GENETIC

Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation

Subjects not administered Neoadjuvant Pembrolizumab

Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide

Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)

Intervention Type GENETIC

Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation

Interventions

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Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)

Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Triple negative breast cancer
* Subjects administered neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not
* Non pCR patients who are undergoing surgery after neoadjuvant chemotherapy
* Sign to informed consent

Exclusion Criteria

* Patients with difficulty in obtaining sufficient samples
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yeon Hee Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yeon Hee Park, MD, Ph.D

Role: CONTACT

82-2-3410-1780

Facility Contacts

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Yeon Hee Park, MD, Ph.D

Role: primary

82-2-3410-1780

Other Identifiers

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2023-02-019

Identifier Type: -

Identifier Source: org_study_id

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