STEMVAC Vaccine for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Natasha Hunter, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults with triple-negative breast cancer who still have moderate or extensive cancer left after standard chemotherapy and surgery. Participants must be in good general health, not pregnant or breastfeeding, and cannot have certain heart conditions, autoimmune diseases needing treatment, or active infections like HIV or hepatitis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive STEMVAC with GM-CSF or GM-CSF alone intradermally every 3 weeks for 3 doses, followed by booster vaccines at 9 weeks and 18 weeks after the third dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 6 months for 3 years
What Are the Treatments Tested in This Trial?
Interventions
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
- Recombinant Granulocyte-Macrophage Colony-Stimulating Factor
Trial Overview
The study tests a new vaccine called STEMVAC (with GM-CSF) given after surgery to see if it helps prevent the return of triple-negative breast cancer. All participants will also receive standard follow-up care. The trial randomly assigns patients to groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive STEMVAC with GM-CSF 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.
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 after booster 1. Patients also undergo collection of blood samples throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
United States Department of Defense
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.