Preoperative Low Dose Azacitidine Treatment in High-Risk Early Stage Breast Cancer A Phase 2 Study Evaluating Immune Cell Changes in Tumors

What this Trial Is About

Researchers are evaluating the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes TILs in primary tumors from patients with high-risk early stage breast cancer. The study aims to compare TIL counts before and after treatment using statistical tests while considering other clinical factors and tumor characteristics. This is a Phase 2 treatment trial focused on assessing changes in TILs as well as clinical response and safety. Participants will receive azacitidine at a dose of 50 mgm2 given subcutaneously once daily for five consecutive days. Before each dose, ondansetron will be given to help prevent nausea. The study includes screening evaluations, pre-treatment biopsy, azacitidine treatment visits over five days, and a post-study biopsy follow-up visit. Various assessments, including physical exams, vital signs, blood tests, and tumor tissue analysis, will be conducted throughout these visits. During the study, participants will undergo medical history review, physical exams, laboratory tests including blood chemistries and pregnancy tests, and tumor assessments. Researchers will monitor adverse events and treatment tolerability. The primary outcome is the change in TIL count two weeks after the first azacitidine dose. Secondary outcomes include clinical response, safety, disease-free survival, and overall survival measured up to two years. The total participation timeline includes screening within 30 days prior to treatment and follow-up visits after treatment completion.

BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer