A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

  • End date
    Jun 1, 2023
  • participants needed
  • sponsor
    Mayo Clinic
Updated on 16 February 2022
platelet count
breast cancer
endocrine therapy
neutrophil count
hormone therapy
carcinoma in situ
aromatase inhibitor
therapeutic conventional surgery
core needle biopsy


This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.



I. To determine the safety and tolerability of multi-epitope HER2 peptide vaccine H2NVAC (H2NVAC) given every 2 weeks for 4 cycles in patients with HER2 expressing ductal carcinoma in situ (DCIS) prior to surgery.

II. To determine the dose level of H2NVAC with maximum systemic and intratumoral immunogenicity as measured by activated HER2-specific T lymphocytes or high-affinity antibodies.


I. To determine intratumoral immunogenicity of H2NVAC in patients with HER2-expressing DCIS.

II. To assess the complete pathological response after 4 cycles of neoadjuvant H2NVAC.

III. To assess the systemic immunogenicity of H2NVAC in patients with HER2-expressing DCIS.

IV. To assess changes in HER2 expression in the DCIS after 4 cycles of neoadjuvant H2NVAC.

V. To assess the distribution of the helper T cell response among T helper cell differentiation states.

OUTLINE: This is a dose-escalation study of multi-epitope HER2 peptide vaccine H2NVAC.

Prior to standard of care surgery, patients receive granulocyte macrophage-colony-stimulating factor (GM-CSF) admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day

  1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, and 12 months after surgery and optionally at 18 and 24 months after surgery.

Condition Breast Ductal Carcinoma In Situ
Treatment therapeutic conventional surgery, Granulocyte-Macrophage Colony-Stimulating Factor, Multi-epitope HER2 Peptide Vaccine H2NVAC
Clinical Study IdentifierNCT04144023
SponsorMayo Clinic
Last Modified on16 February 2022


Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Patients must not have received any prior therapy for current DCIS
Note: Patients who received tamoxifen, raloxifene, aromatase inhibitor or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least 2 months prior to baseline study biopsy if they chose to have this collected
Note: Concurrent use of endocrine therapy during the vaccination/preoperative period is not allowed. However, standard adjuvant endocrine therapy with tamoxifen or aromatase inhibitor after completion of vaccination and surgery is allowed
Any degree of HER2 expression as performed on the diagnostic clinical biopsy defined
Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis
by immunohistochemistry +1, +2, or +3
Note: suspected microinvasion or definite microinvasion (< 0.1 mm invasion) on core biopsy is allowed
Patients must have evidence of at least 1.0 cm of disease extent based on mammogram, ultrasound, or magnetic resonance (MRI) imaging
Patients will be asked to have an additional research biopsy prior to the first
Absolute neutrophil count (ANC) >= 1500/mm^3 (less than or equal to 28 days prior to registration)
Platelet count >= 75,000/mm^3 (less than or equal to 28 days prior to registration)
vaccination. This is not mandatory for participation
Hemoglobin >= 9.0 g/dL (less than or equal to 28 days prior to registration)
Creatinine =< 2 x upper limit of normal (ULN) (less than or equal to 28 days prior to registration)
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x ULN (less than or equal to 28 days prior to registration)
Albumin >= 3 g/dL (less than or equal to 28 days prior to registration)
Negative serum pregnancy test done =< 7 days prior to Registration, for women of childbearing potential only
Willing to employ adequate contraception from the time of Registration through 6 months after the final vaccine cycle
Note: Adequate contraception methods include birth control pills, barrier device, intrauterine device
Capable of providing valid informed consent
Willing to return to enrolling institution for all study visits (immunizations, blood draws, etc)
Capable of understanding the investigative nature, potential risks, and benefits of
Willing to provide blood samples for correlative research purposes
Willing to receive a tetanus vaccination if subject has not had one within the past year
the study

Exclusion Criteria

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
Pregnant women
Nursing women unwilling to stop breast feeding
Women of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids
Note: Must be off systemic steroids greater than or equal to 90 days prior to Registration. However, topical steroids, inhalants or steroid eye drops are permitted
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
Uncontrolled acute or chronic medical conditions including, but not limited to the
of the investigator, would make the patient inappropriate for entry into this
study or interfere significantly with the proper assessment of safety and
Active infection requiring antibiotics
toxicity of the prescribed regimens
Congestive heart failure with New York Heart Association class III or IV moderate to severe objective evidence of cardiovascular disease
Myocardial infarction or stroke less than or equal to 6 months prior to registration
Receiving any other investigational agent
Other active malignancy at time of registration or less than or equal to the last three years prior to registration. EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active
NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (cytotoxics, monoclonal antibodies, small molecule inhibitors) for their cancer
infection, symptomatic congestive heart failure, unstable angina pectoris
cardiac arrhythmia, or psychiatric illness/social situations that would limit
Known history of autoimmune disease, including type I diabetes
compliance with study requirements
Any prior hypersensitivity or adverse reaction to GM-CSF
History of trastuzumab-related cardiac toxicity requiring interruption or discontinuation of therapy, even if left ventricular ejection fraction (LVEF) fully recovered
Baseline LVEF with a value below 55%
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
History of myocardial infarction =< 168 days (6 months) prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias
History of ipsilateral radiation to the current affected breast with DCIS
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