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NCT02063724 · ClinicalTrials.gov registry record · Phase 1
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02063724: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02063724 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02063724, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.
Primary Outcome
Number of participants willing and able to complete treatment regimen, to address feasibility.
Interventions
- BIOLOGICAL HER-2 pulsed Dendritic Cell Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2022-09 |
| Phase | Phase 1 |
What the finished NCT02063724 record still lists
NCT02063724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which HER-2 pulsed Dendritic Cell Vaccine is the first listed.
NCT02063724 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02063724 about?
NCT02063724 is a clinical study titled "HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer". The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence ex...
What is the current status of trial NCT02063724?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-10-01. Estimated completion is 2022-09.
What interventions are being tested in trial NCT02063724?
The interventions under investigation include: HER-2 pulsed Dendritic Cell Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02063724?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02063724's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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