Phase 1B Clinical Trial of a Candidate Breast Cancer Prevention Vaccine
Abstract
This project involves a phase 1b clinical trial in breast cancer patients undergoing neoadjuvant endocrine therapy. Sixty subjects with mammaglobin-A-expressing breast cancer will be randomized in a 1:1 ratio to neoadjuvant endocrine therapy alone, or neoadjuvant endocrine therapy plus mammaglobin-A DNA vaccination. The primary objective is to assess the safety of the mammaglobin-A DNA vaccine. The secondary objective is to assess the ability of the mammaglobin-A DNA vaccine to induce an immune response to mammaglobin-A. During the first year of the project most efforts focused on optimizing patient awareness and accrual. Several protocol amendments were implemented earlier in the year to improve accrual. Additionally, we implemented screening of both medical and surgical oncologists' clinic schedules, and added Dr. Bisi Ademuyiwa, a Breast Cancer Medical Oncologist, to the trial team. To increase awareness a patient information package was prepared that explains the goal and details of the clinical trial. To date, a total of 12 patients signed the screening consent. Of these, 5 patients were eligible and 4/5 were randomized to the trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2021
- Accession Number
- AD1151180
Entities
People
- William E. Gillanders
Organizations
- Washington University in St. Louis