H2NVAC Vaccine for Breast Cancer
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial requires that you stop any endocrine therapy (like tamoxifen or aromatase inhibitors) at least 2 months before starting the study. You cannot use these therapies during the vaccination period, but you can resume them after the vaccination and surgery.
What data supports the effectiveness of the H2NVAC Vaccine for Breast Cancer?
Research shows that combining HER2-targeted peptide vaccines with other treatments like trastuzumab can enhance immune responses and potentially prevent cancer recurrence. Additionally, multi-epitope vaccines, like H2NVAC, have been shown to induce stronger immune responses in preclinical studies, suggesting they could be effective in treating HER2-positive breast cancer.12345
Is the H2NVAC Vaccine for Breast Cancer safe for humans?
How is the H2NVAC vaccine treatment for breast cancer different from other treatments?
The H2NVAC vaccine is unique because it targets multiple specific parts of the HER2 protein, which is often overexpressed in breast cancer, to stimulate a stronger immune response. This multi-epitope approach aims to enhance the body's ability to fight cancer cells more effectively compared to treatments that target a single epitope.1891011
What is the purpose of this trial?
This trial studies the H2NVAC vaccine, which aims to boost the immune system to fight breast cancer in patients with HER2-expressing DCIS. The vaccine helps the body recognize and attack cancer cells by targeting the HER2 protein. H2NVAC is a vaccine targeting the HER2 protein, similar to other HER2/neu vaccines being tested for their ability to elicit immune responses against breast cancer.
Research Team
Amy C. Degnim, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for patients with operable ductal carcinoma in situ of the breast expressing any level of HER2, who haven't had prior treatment for it. They must have good blood counts and organ function, not be pregnant or breastfeeding, agree to use contraception, and can't be on certain other treatments. People with severe diseases or conditions that could interfere with the study are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally. Treatment repeats every 14 days for up to 4 cycles for dose levels 1 and 2, and on days 1, 4, 8, and 15 for 1 cycle for dose level 3.
Surgery
Standard of care surgery is performed after completion of the vaccine treatment cycles.
Follow-up
Participants are monitored for safety and effectiveness after surgery at 3, 6, and 12 months, with optional follow-up at 18 and 24 months.
Treatment Details
Interventions
- Multi-epitope HER2 Peptide Vaccine H2NVAC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator