43 Participants Needed

H2NVAC Vaccine for Breast Cancer

Recruiting at 1 trial location
CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Initial safety analysis from a phase II trial of a similar HER2-peptide vaccine showed no significant differences in toxicity, including heart-related issues, compared to standard treatment. This suggests that the vaccine is generally safe for humans.12367

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

AC

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

Your white blood cell count is normal.
Willing to provide blood samples for correlative research purposes
I have not had any treatment for my current DCIS.
See 19 more

Exclusion Criteria

Pregnant women
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
You have a known autoimmune disease, like type I diabetes.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 weeks
4 visits (in-person) for dose levels 1 and 2, 4 visits (in-person) 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.

24 months
3 visits (in-person) with optional additional visits

Treatment Details

Interventions

  • Multi-epitope HER2 Peptide Vaccine H2NVAC
Trial Overview The trial is testing a new vaccine called H2NVAC given before surgery to stimulate immune cells against breast cancer in those with HER2-expressing ductal carcinoma in situ. It aims to find the best dose and observe side effects while also collecting biospecimens and conducting heart checks.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)Experimental Treatment6 Interventions
Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo ECHO and collection of blood samples throughout the trial and may undergo biopsy on trial.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

The MFCH401-based tricomponent anti-HER2 cancer vaccine significantly enhances the immune response against HER2-overexpressing breast cancer cells, showing stronger humoral and cellular immunity compared to simpler two-component vaccines.
Incorporating the lipopeptide Pam3CSK4 into the vaccine formulation was found to provide superior immunostimulatory activity, improving the overall effectiveness of the vaccine in targeting breast cancer.
Synthesis and functional studies of self-adjuvanting multicomponent anti-HER2 cancer vaccines.Feng, Q., Yu, X., Wang, Y., et al.[2022]
The E75 vaccine, tested in two Phase II trials with 186 breast cancer patients, shows promise in preventing disease recurrence, particularly in high-risk individuals with node-positive and node-negative disease.
The trials highlighted the importance of optimal dosing and booster inoculations for enhancing the vaccine's effectiveness, while also providing insights into the immunologic responses and potential clinical benefits of this targeted therapy.
The E75 HER2/neu peptide vaccine.Mittendorf, EA., Holmes, JP., Ponniah, S., et al.[2022]
HER2 is a key target in breast cancer treatment, as it is over-expressed in 20-30% of cases, and therapies using HER2-directed monoclonal antibodies have significantly improved outcomes for patients with these tumors.
While early phase clinical trials have shown promise for HER2 vaccines, late phase trials have not yet produced clinically relevant results, highlighting the need for further research in this area.
The clinical development of vaccines for HER2+ breast cancer: Current landscape and future perspectives.Costa, RLB., Soliman, H., Czerniecki, BJ.[2017]

References

Synthesis and functional studies of self-adjuvanting multicomponent anti-HER2 cancer vaccines. [2022]
The E75 HER2/neu peptide vaccine. [2022]
The clinical development of vaccines for HER2+ breast cancer: Current landscape and future perspectives. [2017]
HER2-Positive Breast Cancer Immunotherapy: A Focus on Vaccine Development. [2020]
Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer. [2022]
AE37: a novel T-cell-eliciting vaccine for breast cancer. [2014]
Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors. [2020]
Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. [2020]
HER-2/neu (657-665) represents an immunogenic epitope of HER-2/neu oncoprotein with potent antitumor properties. [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
A degenerate HLA-DR epitope pool of HER-2/neu reveals a novel in vivo immunodominant epitope, HER-2/neu88-102. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
A chimeric multi-human epidermal growth factor receptor-2 B cell epitope peptide vaccine mediates superior antitumor responses. [2020]
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