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NCT00841399 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients
A Phase 1 study, sponsored by COL George Peoples, MD, FACS.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT00841399: Completed Phase 1 study, sponsored by COL George Peoples, MD, FACS.
NCT00841399 is a Phase 1 study that has completed, run by COL George Peoples, MD, FACS. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841399, a Phase 1 study, has completed, sponsored by COL George Peoples, MD, FACS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purposes of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) 2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine 3. To evaluate the in vivo cellular immune response to the peptide vaccine 4. To evaluate time to recurrence in the vaccinated patients vs. matched controls
Interventions
- BIOLOGICAL E75 + GM-CSF vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2001-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT00841399 record still lists
NCT00841399 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 1 intervention - of which E75 + GM-CSF vaccine is the first listed.
NCT00841399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00841399 about?
NCT00841399 is a clinical study titled "Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients". The purposes of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) 2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine 3. To evaluate the in vivo cellular immune response to the pep...
What is the current status of trial NCT00841399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2001-07. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00841399?
The interventions under investigation include: E75 + GM-CSF vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00841399?
This trial is sponsored by COL George Peoples, MD, FACS, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00841399's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 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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