RecruitingBreast Ductal Carcinoma In Situ
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
Eligible age
18+ yrs
Accepts
Women
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT04144023 · last updated 2026-03-05