University of Washington
This phase II trial evaluates whether a multi-antigen vaccine called STEMVAC improves disease-free survival after surgery in patients with triple-negative breast cancer (TNBC) and moderate or extensive residual cancer burden. TNBC has an aggressive clinical course and poorer disease-free survival compared to other subtypes. While patients who have no remaining tumor in the breast or lymph nodes after surgery have excellent long-term outcomes, patients with moderate or extensive residual cancer burden remain at high risk for early disease return and poorer prognosis. STEMVAC is designed to target proteins that tumor cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Giving STEMVAC after surgery may improve disease-free survival rates in TNBC patients with moderate or extensive residual cancer burden.
OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid deoxyribonucleic acid (DNA) vaccine (STEMVAC) with recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) intradermally (ID) every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial. ARM B: Patients receive GM-CSF ID every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks afte…
Inclusion Criteria: * At least 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 * Triple-negative breast cancer as determined by the treating oncologist * Completed standard of care neoadjuvant chemotherapy in the opinion of their treating oncologist * Patients whose tumors progress on neoadjuvant therapy may be enrolled * No clinical evidence of local or distant recurrence * Plan to receive standard of care adjuvant directed therapy * Completed standard of care locoregional treatment, including definitive breast and lymph node surgery followed by st…
Given ID
Given ID
Undergo collection of blood samples