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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new vaccine for patients with HER2 expressing ductal carcinoma in situ. The vaccine is designed to stimulate white blood cells in hopes of increasing immune response and protecting 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.Check my eligibility
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.See study design
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.
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My breast cancer has not spread beyond the milk ducts and does not affect lymph nodes or distant parts of my body.
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I understand the study and can agree to participate.
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My cancer shows some level of HER2 protein.
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My scans show a tumor larger than 0.5 cm.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 2
~1720
Granulocyte-Macrophage Colony-Stimulating Factor
2017
Completed Phase 1
~20
Biopsy
2014
Completed Phase 4
~1090
Echocardiography
2013
Completed Phase 4
~11670
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,704 Previous Clinical Trials
40,931,418 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,234 Previous Clinical Trials
3,771,813 Total Patients Enrolled
83 Trials studying Breast Cancer
13,796 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment still available to interested participants?
"This research endeavour is recruiting patients, according to information posted on clinicaltrials.gov. It was first advertised shortly after April 1st 2019 and the most recent update occurred during December 2021."
Answered by AI
Has the Multi-epitope HER2 Peptide Vaccine H2NVAC been granted official clearance from the FDA?
"There is minimal evidence in support of the safety and efficacy of Multi-epitope HER2 Peptide Vaccine H2NVAC, so it has been assigned a rating of 1."
Answered by AI
What is the current capacity for participants in this trial?
"Affirmative. Clinicaltrials.gov data shows that this medical trial, which was first listed on April 1st 2019, is actively seeking volunteers for participation. The study requires 43 people to be recruited at two different sites."
Answered by AI
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