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Cancer Vaccine

HER-2 DC Vaccine for Recurrence of Breast Cancer (Neoadjuvant Trial)

Phase 1
Waitlist Available
Led By Brian Czerniecki, M.D., Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years follow-up
Awards & highlights

Neoadjuvant Trial Summary

This trial will test a new vaccine for safety and effectiveness in treating breast cancer.

Who is the study for?
This trial is for women over 18 with HER-2 positive stage I - III breast cancer that remains after neoadjuvant chemotherapy. They must not be pregnant, have a good performance status (able to carry out daily activities), and agree to use birth control. Excluded are those who are pregnant or breastfeeding, HIV or hepatitis C positive, have certain blood clotting disorders, heart issues, or other illnesses/medications that could affect the study.Check my eligibility
What is being tested?
The trial is testing the safety and immune response of a new vaccine called HER-2 pulsed DC1 in patients at high risk of breast cancer recurrence post-treatment. It also aims to see if circulating tumor cells can indicate how well the vaccine works.See study design
What are the potential side effects?
While specific side effects aren't listed here, vaccines like this one may cause reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, headache and possibly allergic responses.

Neoadjuvant Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is HER-2 positive and remains after initial chemotherapy.
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I am of childbearing age and have a negative pregnancy test.
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I agree to use birth control during the study.
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I am a woman aged 18 or older.

Neoadjuvant Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Treatment Related Adverse Events
Participation Compliance
Secondary outcome measures
Anti-HER2 Immunity
Immunogenicity

Side effects data

From 2022 Phase 1 trial • 15 Patients • NCT02063724
60%
Hypertension
13%
Tingling
13%
Chills
13%
Fever
13%
Citrate toxicity
7%
Fatigue
7%
Anxiety
7%
Allergic reaction to pheresis
7%
Bruising at site of injection (LEFT groin)
7%
Lip paresthesia
7%
Muscle aches
7%
Hypotension
7%
Axillary fullness
7%
Rash
7%
Bone pain
7%
Meningioma
7%
Port infection
7%
Cellulitis port site
7%
Seizures
7%
Hyperglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
HER-2 Pulsed Dendritic Cell Vaccine

Neoadjuvant Trial Design

1Treatment groups
Experimental Treatment
Group I: HER-2 Pulsed Dendritic Cell VaccineExperimental Treatment1 Intervention
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HER-2 pulsed Dendritic Cell Vaccine
2014
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,984 Total Patients Enrolled
40 Trials studying Breast Cancer
5,752 Patients Enrolled for Breast Cancer
Brian Czerniecki, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
15 Total Patients Enrolled
2 Trials studying Breast Cancer
15 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Research Study Groups: HER-2 Pulsed Dendritic Cell Vaccine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~1 spots leftby Mar 2025