Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
Emory University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer * Estrogen receptor IHC expression ≤10%; progesterone receptor IHC expression ≤ 10%; HER2 negative * HER2 negativity is defined as either of the following by local laboratory assessment: * IHC 0, 1+, or 2+ and In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \<2.0 or single probe average HER2 gene copy number \<4 signals/cell) * No prior chemotherapy, endocrine therapy, or immunotherapy * Willingness and ability of the subject to comply with scheduled visits, standa…
Location
- Emory University/Winship Cancer InstituteAtlanta, Georgia