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NCT00854789 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by COL George Peoples, MD, FACS.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 2
- Study locations
NCT00854789: Completed Phase 1 study of Breast Cancer, sponsored by COL George Peoples, MD, FACS.
NCT00854789 is a Phase 1 study of Breast Cancer that has completed, run by COL George Peoples, MD, FACS. The registered enrollment target is 95 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00854789, a Phase 1 study of Breast Cancer, has completed, sponsored by COL George Peoples, MD, FACS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objectives of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) in node-negative breast cancer patients. 2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in vivo cellular immune response to the peptide vaccine yet limit toxicity. 3. To determine the optimal inoculation schedule to elicit an in vivo cellular immune response to the peptide vaccine. 4. To correlate the efficiency of eliciting an in vivo cellular immune response to the peptide vaccine with the degree of HER2/neu expression in the patient's tumor.
Conditions Studied
Interventions
- BIOLOGICAL E75 + GM-CSF vaccine
Study Locations (2)
District of Columbia
- Walter Reed Army Medical Center - Washington D.C.
Pennsylvania
- Windber Medical Center - Windber
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2002-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT00854789 record still lists
NCT00854789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which E75 + GM-CSF vaccine is the first listed.
NCT00854789 reports a single indexed study location in District of Columbia, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00854789 about?
NCT00854789 is a clinical study titled "Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer". The objectives of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) in node-negative breast cancer patients. 2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in vivo cellular immune response ...
What is the current status of trial NCT00854789?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2002-12. Estimated completion is 2013-03.
What conditions does trial NCT00854789 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00854789?
The interventions under investigation include: E75 + GM-CSF vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00854789?
This trial is sponsored by COL George Peoples, MD, FACS, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00854789 being conducted?
This trial has 2 study locations across District of Columbia, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00854789's enrollment target sits among peer trials
95 608th of 1224 higher than 615 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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