HER2 Vaccine for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require corticosteroids or other immunosuppressive drugs, or if you are receiving or planning to receive adjuvant CDK4/6 inhibitor therapy.
What data supports the effectiveness of the HER2 Vaccine treatment for breast cancer?
Is the HER2 vaccine safe for humans?
How is the HER2 Vaccine treatment different from other breast cancer treatments?
The HER2 Vaccine is unique because it aims to stimulate the body's immune system to target and attack HER2-positive breast cancer cells, unlike traditional treatments that use monoclonal antibodies or kinase inhibitors. This vaccine approach is designed to be safe by avoiding the oncogenic activity associated with HER2, and it can potentially offer a new way to treat patients who do not respond to existing therapies.12578
What is the purpose of this trial?
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
Research Team
Pravin Kaumaya, PhD
Principal Investigator
Indiana University
Eligibility Criteria
This trial is for women over 18 with HER2 positive breast cancer who've finished chemo or radiation at least a month ago and had six months of HER2 therapy. They must not be pregnant, have serious autoimmune diseases, active infections needing antibiotics, other cancers, or heart/lung issues. A negative pregnancy test and agreement to use contraception are required.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the investigational HER2 vaccine intramuscularly every 21 days for three doses, with a booster at 6 months
Follow-up
Participants are monitored for immune response and safety through ELISA quantification and adverse event assessment
Long-term follow-up
Participants may be monitored for long-term safety and immune response
Treatment Details
Interventions
- HER2 Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pravin T.P Kaumaya
Lead Sponsor