Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab

Breast Cancer Stage II Clinical Trial

Official title: Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab

Status Recruiting

Clinical Trial Summary

This research study is a prospective, single arm, pilot study, designed to evaluate the correlation between the immune and clinical responses of subjects with untreated Stage II-III triple negative breast cancer (TNBC) undergoing standard of care neoadjuvant chemo- immunotherapy.

Clinical Trial Description

Primary Objective:

I. To determine whether standard of care neoadjuvant chemo-immunotherapy leads to the induction of a pro-inflammatory cytokine milieu (characterized by high IFN- γ, IFN-α, IL-6 and low TGF-β) in the blood which is induced within 24 hours of treatment initiation, persists through the course of the therapy and is associated with pathologic complete response in the tissue.

Secondary Objectives:

I. To determine whether the spatially resolved tissue TGF-β induced transcriptomic signatures or lack of innate interferon inducible genes/effector CD8 modules are abundant in tumors from TNBC patients that do not show pathologic complete response in the tissue at the end of standard of care neoadjuvant chemo- immunotherapy. ;

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Cancer Triple Negative
• Breast Neoplasms
• Triple Negative Breast Neoplasms

• NCT number: NCT05877859
• Study type: Observational
• Source: Emory University
• Contact: Ruth Sacks, MD
• Phone: 404-778-1900
• Email: rlsacks@emory.edu
• Status: Recruiting
• Start date: May 30, 2023
• Completion date: April 10, 2026