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

NCT05910710 | Unknown

• 1 other identifier: 2023-02-019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Triple Negative Breast Cancer; Neoadjuvant Chemotherapy; Pembrolizumab; Tumor Microenvironment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Subjects administered Neoadjuvant Pembrolizumab

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

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

Subjects not administered Neoadjuvant Pembrolizumab

Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide

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

Interventions

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

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

Subjects administered Neoadjuvant Pembrolizumab; Subjects not administered Neoadjuvant Pembrolizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally advanced triple negative breast cancer subjects who were administered neoadjuvant chemotherapy with Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not

You may qualify if:

• 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

You may not qualify if:

• Patients with difficulty in obtaining sufficient samples

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood : Germline DNA Tissue : DNA/RNA

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yeon Hee Park, MD, Ph.D

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 20, 2023
• Study Start: March 2, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 20, 2023

Record last verified: 2023-06

Locations

KR (1)