Actively Recruiting
A Phase IB Trial of Neoadjuvant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS
Led by Mayo Clinic · Updated on 2026-03-05
43
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a vaccine called H2NVAC in patients with HER2-expressing ductal carcinoma in situ (DCIS), a type of early breast cancer. This phase Ib trial aims to study the side effects and determine the best dose of H2NVAC given before surgery. The vaccine is designed to stimulate the immune system, specifically targeting HER2-expressing cancer cells to potentially improve the body's response against breast cancer. The trial involves giving patients the H2NVAC vaccine combined with granulocyte macrophage-colony-stimulating factor (GM-CSF) through intradermal injections. Patients receive up to four treatments, either every 14 days for dose levels 1 and 2 or on days 1, 4, 8, and 15 for dose level 3. After completing the vaccine treatments, patients undergo standard breast surgery. During the study, participants will have echocardiography (heart ultrasound) and blood samples collected, and biopsies may be performed. Participants are followed for safety and immune response monitoring up to two years after surgery, with follow-up visits at 3, 6, 12 months, and optionally at 18 and 24 months. Researchers will track adverse events, immune system activity, and changes in the tumor after vaccination. Blood tests, imaging, and biopsies help assess how the vaccine affects the cancer and the patient's immune system over time.
CONDITIONS
Brief 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 less than or equal to 2
- No prior therapy for current ductal carcinoma in situ (DCIS)
- Any degree of HER2 expression on diagnostic biopsy (immunohistochemistry +1, +2, or +3)
- Histologically confirmed operable DCIS with no lymph node involvement or distant metastasis
- Disease extent of at least 0.5 cm based on imaging (mammogram, ultrasound, or MRI)
- Absolute neutrophil count 1500/mm^3 or higher within 28 days before registration
- Platelet count 75,000/mm^3 or higher within 28 days before registration
- Hemoglobin 9.0 g/dL or higher within 28 days before registration
- Creatinine less than or equal to 2 times upper limit of normal within 28 days before registration
- AST (SGOT) less than or equal to 2 times upper limit of normal within 28 days before registration
- Albumin 3 g/dL or higher within 28 days before registration
- Negative pregnancy test within 7 days before registration for women of childbearing potential
- Willing to use adequate contraception from registration through 6 months after last vaccine cycle
- Able to understand study risks and provide informed consent
- Willing to attend all study visits and provide blood samples for research
- Willing to receive tetanus vaccination if not received within the past year
You will not qualify if you...
- Pregnant or nursing women unwilling to stop breastfeeding
- Women of childbearing potential unwilling to use adequate contraception during study and 6 months after
- Severe systemic illnesses or diseases that interfere with safety assessments
- Immunocompromised patients including HIV positive or on chronic steroids (unless physiologic replacement)
- Uncontrolled infections or serious heart conditions, including recent heart attack or stroke within 6 months
- Receiving any other investigational agent
- Other active cancers within past 3 years except non-melanoma skin cancer or in situ cancers
- Active autoimmune disease requiring systemic treatment within 30 days prior to registration
- History of hypersensitivity or adverse reaction to GM-CSF
- History of trastuzumab-related heart toxicity
- Left ventricular ejection fraction below 55%
- Incomplete recovery from prior chemotherapy effects
- Prior radiation to the affected breast with DCIS
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks for dose levels 1 and 2 or 15 days for dose level 3
Participants receive the multi-epitope HER2 peptide vaccine H2NVAC with GM-CSF intradermally before surgery. The vaccine schedule depends on the dose level, with either up to 4 treatments every 14 days or 4 treatments within 1 cycle over 15 days. Echocardiography and blood samples are collected during this period, and biopsy may be performed.
Multiple visits for vaccinations and assessments during treatment
Duration - 1 day (surgery) plus immediate recovery
Participants undergo standard of care surgery to remove ductal carcinoma in situ.
1 hospital visit for surgery
Duration - Up to 24 months after surgery
Participants are followed up after surgery to monitor recovery and safety, including visits at 3, 6, 12 months and optionally 18 and 24 months after surgery.
Visits at 3, 6, 12 months and optional visits at 18 and 24 months post-surgery
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
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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