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Cancer Vaccine

Vaccine for Breast Cancer Recurrence

Phase 2
Waitlist Available
Led By Hyo S. Han, M.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
Must have normal organ and marrow function as defined below: Absolute neutrophil count (ANC) ≥ 1,000/ μL, Platelets ≥ 75,000/ μL, Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), AST/ALT ≤ 3 x institutional upper limit of normal (ULN), Creatinine ≤ 1.5 x institutional upper limit of normal (ULN), Hemoglobin A1C <6.5%, Left ventricular ejection fraction (LVEF) above institutional lower limit of normal (by echocardiogram or MUGA scan within 90 days of registration), Females of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and males must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for three months following the last dose, Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures
Residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing whether two different vaccines can prevent disease recurrence in people who have already had cancer.

Who is the study for?
This trial is for adults over 18 with HER-2 positive breast cancer who've had neoadjuvant chemotherapy and still have some invasive carcinoma. They must be on or recently finished HER-2 targeted therapy, have normal organ/marrow function, agree to contraception use, and not be pregnant. Exclusions include hypersensitivity to GM-CSF adjuvant, HIV/hepatitis B/C infection, major surgery within the last month, other clinical trials participation, uncontrolled illnesses or extended immunosuppressant/corticosteroid use.Check my eligibility
What is being tested?
The study compares two vaccines (DC1 vs. WOKVAC) designed to prevent breast cancer recurrence in patients with a history of HER-2 positive disease. Participants will receive one vaccine during a vaccination phase followed by a booster phase. The main goal is to see how well these vaccines work in extending the time before any potential return of cancer.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions related to their immune system's response to the vaccine such as flu-like symptoms (fever, fatigue), injection site pain or swelling, allergic reactions or possibly more serious autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I still have cancer in my breast or underarm area after chemotherapy before surgery.
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I have stage I-III HER2 positive breast cancer and received specific treatment for over 12 weeks.
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I finished my last chemotherapy or radiation over a month ago and have recovered from the side effects.
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I am 18 years old or older.
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I am fully active or can carry out light work.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunogenicity
Secondary outcome measures
Disease-free Survival (DFS)

Trial Design

2Treatment groups
Active Control
Group I: Dendritic Cell (DC1) VaccineActive Control1 Intervention
The vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.
Group II: pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)Active Control1 Intervention
The vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,376 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
864 Previous Clinical Trials
327,480 Total Patients Enrolled
38 Trials studying Breast Cancer
103,466 Patients Enrolled for Breast Cancer
Hyo S. Han, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Breast Cancer
10 Patients Enrolled for Breast Cancer

Media Library

DC1 Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03384914 — Phase 2
Breast Cancer Research Study Groups: Dendritic Cell (DC1) Vaccine, pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)
Breast Cancer Clinical Trial 2023: DC1 Vaccine Highlights & Side Effects. Trial Name: NCT03384914 — Phase 2
DC1 Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03384914 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the regulatory status of Dendritic Cell (DC1) Vaccine?

"An evaluation of the safety profile for Dendritic Cell (DC1) Vaccine yields a score of 2. This Phase 2 trial has limited efficacy data, but some information on its potential safety."

Answered by AI

Is there an ongoing call for participants in this medical investigation?

"According to the clinicaltrials.gov listing, this research is recruiting patients at present. The initial posting of the study was on February 19th, 2018 and it underwent its most recent update on August 18th 2022."

Answered by AI

In which geographic regions is this clinical research currently being conducted?

"Indiana University – Melvin and Bren Simon Cancer Center in Indianapolis, Roswell Park Comprehensive Cancer Center in Buffalo, and H. Lee Moffitt Cancer Centre & Research Institute in Tampa are amongst the sites taking part in this clinical trial with additional locations across America contributing too."

Answered by AI

How many participants are eligible to join this medical trial?

"Affirmative. As outlined on clinicaltrials.gov, this medical trial is currently looking to enroll 110 individuals at 7 different sites. The initial post date was February 19th 2018 and the most recent update occurred August 18th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
2018. "Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03384914.
All > Breast Cancer New York
~24 spots leftby Dec 2025
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