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NCT03384914 · ClinicalTrials.gov registry record · Phase 2
Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
A Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
- 7
- Study locations
NCT03384914: Active Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03384914 is a Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 119 participants, below the 234-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (49% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03384914, a Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
The primary immunogenicity outcome for both arms of this trial will be the summation of spots (ELISPOT) for 6 distinct peptides and reported as total SFC/10\^6 cells. A value \>150 defines an immune response.
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 |
What the registry record for NCT03384914 still lists
NCT03384914 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 234-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (49% lower).
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.
NCT03384914 lists 7 locations in 7 states (Florida, Georgia, Indiana).
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.
What interventions are being tested in trial NCT03384914?
The interventions under investigation include: DC1 Vaccine (BIOLOGICAL), WOKVAC Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03384914?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03384914's enrollment target sits among peer trials
119 26th of 58 higher than 33 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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