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NCT05910710 Clinical Trial

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

Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05910710
Other study ID # 2023-02-019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2, 2023
Est. completion date December 31, 2025

Study information
Verified date June 2023
Source Samsung Medical Center
Contact Yeon Hee Park, MD, Ph.D
Phone 82-2-3410-1780
Email yeonh.park@samsung.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)
Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 3year
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