H2NVAC Vaccine Before Surgery for HER2-Expressing DCIS
This study is testing a vaccine called H2NVAC, given with GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor), before surgery for HER2-expressing Ductal Carcinoma In Situ (DCIS). DCIS is a non-invasive form of breast cancer. The vaccine aims to boost your immune system to fight cancer. Researchers want to find the safest dose and see how well it activates your immune cells against HER2, a protein found on some cancer cells. You may be able to join if you are a woman aged 18 or older with HER2-expressing DCIS who has not had prior treatment for it. The study is currently unclear about its recruitment status and plans to enroll 43 participants. Success will be measured by how safe the vaccine is and how well it creates an immune response.
- Study design
- This is a dose-escalation study, meaning different doses of the vaccine will be tested, followed by a dose expansion. It aims to enroll 43 women.
- What's involved
- You would receive the H2NVAC vaccine and GM-CSF intradermally (just under the skin) every 14 days for up to 4 cycles before standard surgery. You will also have echocardiography tests and blood samples collected.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 2 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04144023
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~43 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Granulocyte-Macrophage Colony-Stimulating FactorMulti-epitope HER2 Peptide Vaccine H2NVACTherapeutic Conventional SurgeryEchocardiography TestBiospecimen CollectionBiopsy Procedure
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events
Measured over 2 years
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesFlorida1
Minnesota1
Study leadership
- Amy C. Degnim, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 by immunohistochemistry +1, +2, or +3
Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis
Note: suspected microinvasion or definite microinvasion (\< 0.1 mm invasion) on core biopsy is allowed
Patients will be asked to have an additional research biopsy prior to the first vaccination. This is not mandatory for participation
Patients must have evidence of at least 0.5 cm of disease extent based on mammogram, ultrasound, or magnetic resonance (MRI) imaging
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)
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, or abstinence
Capable of understanding the investigative nature, potential risks, and benefits of the study
Capable of providing valid informed consent
Willing to return to enrolling institution for all study visits (immunizations, blood draws, etc)
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
Exclusion
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
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
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids, unless physiologic replacement for adrenal or pituitary insufficiency
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
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Uncontrolled acute or chronic medical conditions including, but not limited to the following:
Active infection requiring antibiotics
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)
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
Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration
NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded
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
What this trial measures
- Adverse events2 years
Number of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
- Dose limiting toxicities14 days post vaccination, 2 years
Measured using criteria from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 with grade \>= 3 allergic reaction, grade \>= 3 autoimmune reaction (except for autoimmune encephalitis grade \>=4), grade \>= 3 injection site reaction manifesting as an ulceration, grade \>= 3 neurologic problem, grade \>= 3 non-hematologic or cardiac toxicity, or changes in left ventricular ejection fraction (LVEF) as specified per protocol.