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Cancer Vaccine
HER-2 pulsed Dendritic Cell Vaccine for Breast Cancer (Adjuvant 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Adjuvant Trial Summary
This trial will test a new vaccine for people with HER-2 high or intermediate expression breast cancer. The vaccine will be given after chemotherapy and will be used to try to prevent the cancer from coming back.
Eligible Conditions
- Breast Cancer
Adjuvant Trial 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
Rate of Treatment Regimen Completion
Secondary outcome measures
Immune Response
Occurrence of Treatment Related Adverse Events
Side effects data
From 2022 Phase 1 trial • 15 Patients • NCT0206372460%
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
Adjuvant 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. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
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?
Abramson Cancer Center at Penn MedicineOTHER
387 Previous Clinical Trials
145,680 Total Patients Enrolled
44 Trials studying Breast Cancer
60,834 Patients Enrolled for Breast Cancer
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,477 Total Patients Enrolled
40 Trials studying Breast Cancer
5,765 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaOTHER
359 Previous Clinical Trials
105,080 Total Patients Enrolled
41 Trials studying Breast Cancer
35,318 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have breast cancer and need anti-estrogen therapy, you can still receive vaccinations.
Research Study Groups:
This trial has the following groups:- Group 1: HER-2 Pulsed Dendritic Cell Vaccine
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.
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