Your session is about to expire
← 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
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 belowSelect...
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
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
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
~9870
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.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,872 Previous Clinical Trials
41,010,734 Total Patients Enrolled
946 Trials studying Breast Cancer
1,544,013 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,312 Previous Clinical Trials
2,954,538 Total Patients Enrolled
84 Trials studying Breast Cancer
14,796 Patients Enrolled for Breast Cancer
Amy C DegnimPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
43 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your white blood cell count is normal.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You have a known autoimmune disease, like type I diabetes.I do not have any severe ongoing health issues like serious infections, heart failure, recent heart attack or stroke.I have not had any treatment for my current DCIS.I am a woman able to have children and agree to use birth control during and for 6 months after the trial.I haven't had any cancer except for non-dangerous skin cancer or very early-stage cancers in the last 3 years.My breast cancer has not spread beyond the milk ducts and does not affect lymph nodes or distant parts of my body.Your liver function test results should not be more than double the normal level within the past 28 days before joining the study.Your albumin level in your blood is at least 3 grams per deciliter within the 28 days before enrolling in the study.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.I have a weakened immune system, possibly due to HIV or long-term steroid use.I am not using hormone therapy during my vaccine/pre-surgery period but may use it after.I am willing to consider an extra biopsy for research before my first vaccine dose.I understand the study and can agree to participate.I have had radiation on the same side as my current breast cancer.My cancer shows some level of HER2 protein.Your platelet count needs to be at least 75,000 per cubic millimeter within the last 28 days before enrolling in the study.Your kidney function, measured by creatinine levels, should be within a certain range.I am willing to get a tetanus shot if I haven't had one in the last year.I understand the study's purpose, risks, and potential benefits.Your hemoglobin level needs to be at least 9.0 grams per deciliter within the last 28 days before joining the study.I am breastfeeding and not willing to stop.It's okay if a tiny amount of the cancer has spread into nearby tissue on the core biopsy.I still have side effects from my last chemotherapy.My scans show a tumor larger than 0.5 cm.Your heart's pumping ability is below 55%.I am willing to visit the study site for all required appointments.You have had a bad reaction to GM-CSF before.I can take care of myself but might not be able to do heavy physical work.I haven't had a heart attack in the last 6 months and don't need ongoing therapy for severe heart rhythm problems.I had heart issues from trastuzumab treatment but my heart function has recovered.I stopped taking breast cancer prevention drugs like tamoxifen 2 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (multi-epitope HER2 peptide vaccine H2NVAC, GM-CSF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger