What is H2NVAC studying for HER2-expressing ductal carcinoma in situ?

H2NVAC is being studied as a vaccine to stimulate the immune system against HER2-expressing ductal carcinoma in situ, a form of early breast cancer. This trial aims to find the best dose and assess side effects before surgery. The Mayo Clinic leads this research to evaluate how the vaccine affects the immune response and tumor changes.

Who may be eligible for this HER2-expressing ductal carcinoma in situ clinical trial?

Women aged 18 and older with HER2-expressing ductal carcinoma in situ who have not had prior therapy for the current DCIS may be eligible. Participants must have good heart function, no recent heart attacks or strokes, and be willing to use contraception if of childbearing potential. Please review eligibility criteria for more details.

Is there any cost to participate in this HER2-expressing ductal carcinoma in situ clinical trial?

Study-related care, including the vaccine and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 18Years +

FEMALE

ID04144023

Phase 1B Study of the HER2 Peptide Vaccine H2NVAC Given Before Surgery to Treat HER2-Positive Ductal Carcinoma In Situ of the Breast

Led by Mayo Clinic · Updated on 2026-03-05

Participants Needed

Research Sites

N/A

Total Duration

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 bodys 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 patients immune system over time.

CONDITIONS

Brief Title

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	HER2 Vaccine (H2NVAC) with GM-CSF prior to surgery	Standard surgical management alone
What is it?	Participants receive the investigational multi-epitope HER2 peptide vaccine (H2NVAC) with GM-CSF intradermally, followed by standard surgical removal of the DCIS lesion. The vaccine is administered before surgery as a novel approach to stimulate an immune response against HER2-expressing cells.	Standard management for HER2-expressing ductal carcinoma in situ is surgical removal of the affected tissue, typically via lumpectomy or mastectomy, without preoperative immunotherapy.
Role in trial	Tested as the primary investigational intervention before surgery in a single-group study.	Serves as the clinical reference for current management of DCIS outside clinical trials.
Primary use	Intended to enhance immune response to HER2-expressing DCIS cells before surgery; main goal is to study safety and immune activation.	Removes DCIS lesions to prevent progression to invasive breast cancer; standard definitive treatment.
How it is given/performed	Intradermal injections of HER2 peptide vaccine plus GM-CSF are administered prior to standard surgery (typically lumpectomy or mastectomy), per study protocol.	Patients undergo lumpectomy or mastectomy as indicated, typically without any preoperative immunotherapy.
Evidence status	No published patient outcome data yet; efficacy and safety are being investigated in this early-phase trial.	Strong evidence from multiple studies supports surgery as effective in local control and prevention of invasive breast cancer in DCIS.
Important limitations	As an early-phase single-group study, it does not compare patient outcomes directly with standard care; data on long-term efficacy and safety are not yet available. The vaccine's benefit remains investigational.	Surgery effectively removes DCIS but may be associated with risks such as infection, cosmetic changes, and rare recurrence; does not include immune-based therapies that are investigational in clinical trials.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

FEMALE

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

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Surgery and Immediate Post-operative Care

Duration - 1 day (surgery) plus immediate recovery

Participants undergo standard of care surgery to remove ductal carcinoma in situ.

1 hospital visit for surgery

Follow-up

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

Research Team

Clinical Trials Referral Office

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

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Frequently Asked Questions

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Phase 1B Study of the HER2 Peptide Vaccine H2NVAC Given Before Surgery to Treat HER2-Positive Ductal Carcinoma In Situ of the Breast

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Evaluating a New Fluorescent Needle for Precise Localization...

Patient Navigation Program to Improve Care and Support for W...

Phase 2 Study Comparing Acolbifene 20 mg and Low Dose Tamoxi...

Frequently Asked Questions

What is H2NVAC studying for HER2-expressing ductal carcinoma in situ?

Who may be eligible for this HER2-expressing ductal carcinoma in situ clinical trial?

Is there any cost to participate in this HER2-expressing ductal carcinoma in situ clinical trial?

Will I receive H2NVAC or a placebo?

What tests will be done to monitor my condition during the trial?

What happens after this HER2-expressing ductal carcinoma in situ clinical trial ends?

Can I leave this HER2-expressing ductal carcinoma in situ clinical trial if I change my mind?

Not the Right Trial for You?

On this page

Sponsors

Sponsors

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Evaluating a New Fluorescent Needle for Precise Localization...

Patient Navigation Program to Improve Care and Support for W...

Phase 2 Study Comparing Acolbifene 20 mg and Low Dose Tamoxi...

Frequently Asked Questions

What is H2NVAC studying for HER2-expressing ductal carcinoma in situ?

Who may be eligible for this HER2-expressing ductal carcinoma in situ clinical trial?

Is there any cost to participate in this HER2-expressing ductal carcinoma in situ clinical trial?

Will I receive H2NVAC or a placebo?

What tests will be done to monitor my condition during the trial?

What happens after this HER2-expressing ductal carcinoma in situ clinical trial ends?

Can I leave this HER2-expressing ductal carcinoma in situ clinical trial if I change my mind?

Sponsors