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Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
NCT03384914 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.
Conditions Studied
Interventions
- BIOLOGICAL DC1 Vaccine
- BIOLOGICAL WOKVAC Vaccine
Study Locations (7)
Florida
- H. Lee Moffitt Cancer Center and Research Institute — Tampa
Georgia
- Emory - Winship Cancer Institute — Atlanta
Indiana
- Indiana University - Melvin and Bren Simon Cancer Center — Indianapolis
New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick
New York
- Roswell Park Comprehensive Cancer Center — Buffalo
Ohio
- Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute — Columbus
Washington
- University of Washington, Fred Hutchinson Cancer Research Center — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2018-02-19 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03384914
The ClinicalTrials.gov registry entry for NCT03384914 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 562 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which DC1 Vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03384914 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Florida, Georgia, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03384914 about?
NCT03384914 is a clinical study titled "Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer". The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will ...
What is the current status of trial NCT03384914?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2018-02-19. Estimated completion is 2027-12.
What conditions does trial NCT03384914 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Breast Cancer Female, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage I. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03384914?
The interventions under investigation include: DC1 Vaccine (BIOLOGICAL), WOKVAC Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03384914?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 562 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03384914 being conducted?
This trial has 7 study locations across Florida, Georgia, Indiana, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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