Actively Recruiting
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
Led by Mayo Clinic · Updated on 2026-03-05
43
Participants Needed
2
Research Sites
444 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- No prior therapy for current ductal carcinoma in situ (DCIS)
- Prior preventive breast cancer treatments allowed if stopped at least 2 months before baseline biopsy
- No concurrent endocrine therapy during vaccination and preoperative period
- HER2 expression level of +1, +2, or +3 on diagnostic biopsy
- Histologically confirmed operable DCIS without lymph node or distant metastasis
- Suspected or definite microinvasion smaller than 0.1 mm allowed
- Willing to have an additional research biopsy before first vaccination (optional)
- Disease extent of at least 0.5 cm based on imaging (mammogram, ultrasound, or MRI)
- Absolute neutrophil count (ANC) of at least 1500/mm3 within 28 days before registration
- Platelet count of at least 75,000/mm3 within 28 days before registration
- Hemoglobin level of at least 9.0 g/dL within 28 days before registration
- Creatinine level less than or equal to twice the upper limit of normal within 28 days before registration
- AST (SGOT) less than or equal to twice the upper limit of normal within 28 days before registration
- Albumin level of at least 3 g/dL within 28 days before registration
- Negative pregnancy test within 7 days before registration for women who can become pregnant
- Willing to use adequate contraception from registration through 6 months after final vaccine
- Able to understand study risks and benefits and provide informed consent
- Willing to return for all study visits
- Willing to provide blood samples for research
- Willing to receive tetanus vaccination if none within past year
You will not qualify if you...
- Pregnant or nursing women unwilling to stop breastfeeding
- Women of childbearing potential unwilling to use contraception from registration through 6 months after last vaccine
- Severe systemic illness or other severe disease interfering with safety assessment
- Immunocompromised patients including HIV positive or on chronic steroids (unless physiologic replacement)
- Systemic steroids stopped less than 90 days before registration (topical, inhaled, or eye steroids allowed)
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric conditions limiting compliance
- Active infection requiring antibiotics
- Congestive heart failure with New York Heart Association class III or IV
- Myocardial infarction or stroke within 6 months before registration
- Receiving any other investigational agent
- Other active cancer within 3 years except certain skin or in-situ cancers
- Active autoimmune disease requiring systemic treatment within 30 days before registration
- Prior severe allergic reaction to GM-CSF
- History of trastuzumab-related heart toxicity requiring stopping therapy
- Left ventricular ejection fraction below 55%
- Not fully recovered from prior chemotherapy side effects
- Recent heart attack (within 6 months) or ongoing life-threatening heart arrhythmias
- History of radiation therapy to the affected breast with DCIS
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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