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

Samsung Medical Center

Status: Enrolling

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT05910710

2023-02-019

Details and patient eligibility

About

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)

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Subjects administered Neoadjuvant Pembrolizumab

Description:

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

Treatment:

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

Subjects not administered Neoadjuvant Pembrolizumab

Description:

Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide

Treatment:

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