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Cancer Vaccine

HER2/neu DNA Immunization for Breast Cancer

Phase 1
Waitlist Available
Led By Carlos Dos Anjos, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Karnofsky performance status ≥ 80%
Must not have
History of cardiac disease as defined by any of the following: any prior myocardial infarction, history of documented congestive heart failure, left ventricular ejection fraction below the normal institutional range, use of medications for treatment of angina pectoris, any prior arrhythmia or cardiac valvular disease requiring medication or clinically significant
Active infection requiring antibiotic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 19 or at the discretion of the physician
Awards & highlights

Summary

This trial will evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response in patients with breast cancer.

Who is the study for?
This trial is for adults over 18 with Stage III or metastatic breast cancer that has high levels of HER2. Participants must have finished previous treatments at least 4 weeks prior, can be on hormone therapy/trastuzumab, and should not have severe organ dysfunction or other active cancers. Pregnant women and those with certain heart conditions are excluded.Check my eligibility
What is being tested?
The study tests the safety and immune response to an injected DNA vaccine containing a gene for rat HER2 protein. It aims to immunize patients against their own tumor cells by stimulating antibody and T-cell production in individuals with high HER2 expression tumors.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as pain at the injection site, fever, fatigue, allergic responses, or autoimmune-like symptoms due to immune system activation against body tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I can carry out normal activities with minimal symptoms.
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My cancer is HER2 positive based on specific tests.
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My breast cancer is advanced (Stage III or IV) and HER2 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart disease, including heart attack, heart failure, or other heart conditions.
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I am currently on antibiotics for an infection.
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I have not had any active cancers in the last 5 years, except for non-melanoma skin cancer.
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I have a tumor in my brain or spinal cord.
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I have received more than 600 mg/m2 of epirubicin.
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My blood tests show low white cells or platelets, or high kidney or liver markers.
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I have received more than 360 mg/m2 of doxorubicin.
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I have received a breast cancer vaccine in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 19 or at the discretion of the physician
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 19 or at the discretion of the physician for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The maximum tolerated dose over four dose levels
Secondary outcome measures
A secondary endpoint is to observe patients for any evidence of anti-tumor effect.

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
HER2 ECD DNA.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,738 Total Patients Enrolled
203 Trials studying Breast Cancer
81,543 Patients Enrolled for Breast Cancer
Carlos Dos Anjos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Jedd Wolchok, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Xenogeneic HER2/Neu DNA Immunization (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00393783 — Phase 1
Breast Cancer Research Study Groups: 1
Breast Cancer Clinical Trial 2023: Xenogeneic HER2/Neu DNA Immunization Highlights & Side Effects. Trial Name: NCT00393783 — Phase 1
Xenogeneic HER2/Neu DNA Immunization (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00393783 — Phase 1
~1 spots leftby May 2025
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