T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy

Investigator: Jenny Chang, MD

Study Coordinator: Toniva Boone

Status: Enrolling

ClinicalTrials.gov Number: NCT02957968

Phone: 713.441.0686

Protocol Number: Pro00022835

Description

This study is a two-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. Efficacy will be evaluated in 2 cohorts based on hormone receptor status.
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