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

Samsung Medical Center50 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Triple Negative Breast Cancer Neoadjuvant Chemotherapy Pembrolizumab Tumor Microenvironment

Interventions

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

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes)

Tissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction)

Time frame: 3year

Central Contacts

Yeon Hee Park, MD, Ph.D

CONTACT

82-2-3410-1780 yeonh.park@samsung.com

Data from ClinicalTrials.gov

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