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

Recruiting

• Conditions: Neoadjuvant Chemotherapy; Pembrolizumab; Triple Negative Breast Cancer; Tumor Microenvironment
• Interventions: Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)

• Registration Number: NCT05910710
• Lead Sponsor: Samsung Medical Center

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-20
• Last Update Posted: 2023-06-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects administered Neoadjuvant Pembrolizumab	Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)	Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab
Subjects not administered Neoadjuvant Pembrolizumab	Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)	Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes)	3year	Tissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of