About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Toxicities related to prior exposure to immune checkpoint inhibitors for which immune checkpoint inhibitors cannot be safely continued as determined by study investigator
Germline BRCA1 or BRCA2 mutations with adjuvant olaparib planned within the study period
NOTE: If olaparib is not planned, then these patients are eligible
Symptomatic restrictive cardiomyopathy
Trial design
Treatments tested in this trial
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
- Recombinant Granulocyte-Macrophage Colony-Stimulating Factor
- Biospecimen Collection
Treatment groups
Sponsors and collaborators
University of Washington
Lead sponsor
United States Department of Defense
Collaborator