Cancer Vaccine for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new DNA-based vaccine for patients with advanced breast cancer that doesn't respond well to chemotherapy. The vaccine aims to help the immune system target and destroy cancer cells. Patients receive different doses of the vaccine to find the best one, and their health is monitored over time. DNA vaccination has emerged as an attractive immunotherapeutic approach against cancer due to its simplicity, stability, and safety.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be at least 28 days post chemotherapy, monoclonal antibody therapy, and systemic steroids before enrolling. You can continue taking bisphosphonates, denosumab, and/or endocrine therapy.
What makes the STEMVAC treatment unique for breast cancer?
The STEMVAC treatment is unique because it is a DNA vaccine designed to trigger the immune system to specifically target and destroy breast cancer cells by recognizing multiple cancer-specific proteins. This approach aims to provide a more targeted and long-lasting immune response compared to traditional treatments.12345
What data supports the effectiveness of the treatment CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine for breast cancer?
Research shows that DNA vaccines targeting specific cancer antigens can trigger strong immune responses, as seen with a similar vaccine for glioma that induced protective and therapeutic effects. Additionally, DNA vaccines targeting HER2 in breast cancer have shown promising immune responses, suggesting potential effectiveness for the CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope vaccine.12356
Who Is on the Research Team?
Mary L. Disis
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults with HER2-negative stage III-IV breast cancer who have completed standard treatments and are not currently pregnant or breastfeeding. They should have a life expectancy over 6 months, normal organ function tests, no recent major illnesses or surgeries, and agree to use contraception. Those with autoimmune diseases, seizure disorders, significant heart conditions, or on other treatment studies can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the STEMVAC vaccine with rhuGM-CSF intradermally every 28 days for 3 months. Booster vaccines may be given at 3 and 9 months after the third vaccine.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits twice yearly.
What Are the Treatments Tested in This Trial?
Interventions
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine is already approved in United States for the following indications:
- Triple Negative Breast Cancer
- Non-Small Cell Lung Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Breast Cancer Alliance
Collaborator
Breast Cancer Alliance
Collaborator
United States Department of Defense
Collaborator