What side effects are associated with this type of intervention?

Common treatments for HER2-expressing breast cancer, such as vaccines like H2NVAC and immune checkpoint inhibitors, aim to stimulate the immune system. Side effects of these treatments can include flu-like symptoms (fever, chills, fatigue), injection site reactions, and immune-related adverse events such as skin reactions, endocrine disorders, and inflammation of organs like the lungs and liver. Chemotherapy, often used in conjunction with these treatments, can cause nausea, hair loss, anemia, and increased risk of infections. Targeted therapies like trastuzumab may lead to heart problems and infusion reactions.

What prior FDA approvals exist?

FDA-approved treatments for HER2-positive breast cancer include trastuzumab, pertuzumab, and trastuzumab-emtansine (T-DM1). These drugs target the HER2 receptor, which is overexpressed in some breast cancers, and help to inhibit tumor growth. Fam-trastuzumab deruxtecan is another approved drug that targets HER2 and has shown efficacy in metastatic settings. These treatments, like H2NVAC, aim to enhance the immune response against HER2-expressing breast cancer cells.

What other types of research exist?

Promising novel alternatives to H2NVAC for breast cancer patients include: 1) Immune checkpoint inhibitors such as pembrolizumab and atezolizumab, which enhance the immune system's ability to target cancer cells. 2) Personalized cancer vaccines that use neoantigens specific to the patient's tumor to stimulate an immune response. 3) CAR-T cell therapy, which involves modifying a patient's T cells to better recognize and attack cancer cells. 4) Oncolytic virus therapy, which uses genetically modified viruses to infect and kill cancer cells while stimulating an immune response.

← Back to Search

Cancer Vaccine

H2NVAC Vaccine for Breast Cancer

Phase 1

Recruiting

Led By Amy C Degnim

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have received any prior therapy for current DCIS

Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the H2NVAC vaccine, which aims to boost the immune system to fight breast cancer in patients with HER2-expressing DCIS. The vaccine helps the body recognize and attack cancer cells by targeting the HER2 protein. H2NVAC is a vaccine targeting the HER2 protein, similar to other HER2/neu vaccines being tested for their ability to elicit immune responses against breast cancer.

Who is the study for?

This trial is for patients with operable ductal carcinoma in situ of the breast expressing any level of HER2, who haven't had prior treatment for it. They must have good blood counts and organ function, not be pregnant or breastfeeding, agree to use contraception, and can't be on certain other treatments. People with severe diseases or conditions that could interfere with the study are excluded.

What is being tested?

The trial is testing a new vaccine called H2NVAC given before surgery to stimulate immune cells against breast cancer in those with HER2-expressing ductal carcinoma in situ. It aims to find the best dose and observe side effects while also collecting biospecimens and conducting heart checks.

What are the potential side effects?

Potential side effects include typical vaccine reactions like soreness at injection site, fever, fatigue; as well as possible immune-related responses due to stimulation by GM-CSF (a growth factor used) which may affect different organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have not had any treatment for my current DCIS.

Select...

My breast cancer has not spread beyond the milk ducts and does not affect lymph nodes or distant parts of my body.

Select...

I understand the study and can agree to participate.

Select...

My cancer shows some level of HER2 protein.

Select...

My scans show a tumor larger than 0.5 cm.

Select...

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Select...

I do not have any severe ongoing health issues like serious infections, heart failure, recent heart attack or stroke.

Select...

I have a weakened immune system, possibly due to HIV or long-term steroid use.

Select...

I have had radiation on the same side as my current breast cancer.

Select...

I am breastfeeding and not willing to stop.

Select...

I still have side effects from my last chemotherapy.

Select...

I haven't had a heart attack in the last 6 months and don't need ongoing therapy for severe heart rhythm problems.

Select...

I had heart issues from trastuzumab treatment but my heart function has recovered.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Dose limiting toxicities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)Experimental Treatment6 Interventions

Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo ECHO and collection of blood samples throughout the trial and may undergo biopsy on trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Granulocyte-Macrophage Colony-Stimulating Factor

2017

Completed Phase 1

~20

Biopsy

2014

Completed Phase 4

~1090

Echocardiography

2013

Completed Phase 4

~11580

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9890

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HER2-positive breast cancer include targeted therapies such as trastuzumab, pertuzumab, and trastuzumab-emtansine. These therapies work by binding to the HER2 receptors on cancer cells, inhibiting their growth and survival. Trastuzumab and pertuzumab block the HER2 receptor, preventing cell proliferation, while trastuzumab-emtansine delivers a cytotoxic agent directly to the cancer cells. The H2NVAC vaccine, which stimulates specialized white blood cells to enhance the immune response against HER2-expressing cells, represents a novel approach by leveraging the body's immune system to target and destroy cancer cells. This is crucial for patients as it offers a potential method to improve treatment efficacy and reduce recurrence by harnessing the body's natural defenses.