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

Samsung Medical Center1 site in 1 country50 target enrollmentMarch 2, 2023

ConditionsTriple Negative Breast Cancer Neoadjuvant Chemotherapy Pembrolizumab Tumor Microenvironment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Triple Negative Breast Cancer
Sponsor: Samsung Medical Center
Enrollment: 50
Locations: 1
Primary Endpoint: Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

March 2, 2023

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Yeon Hee Park

Professor

Samsung Medical Center

Eligibility Criteria

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