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NCT00194714 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00194714: Completed Phase 1 study, sponsored by University of Washington.
NCT00194714 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00194714, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides may help increase HER2 specific immunity and immune memory cells.
Primary Outcome
ELIspot: Increased immune response is defined as spots per well (SPW) greater than 2 standard deviations (SD) above baseline value, remained the same if the mean SPW was within 2 SD of the previous value, or decreased if the mean SPW was greater than 2 SD below the previous value. Two SD is equivalent to a P value of .05 in that there is a 95% probability that the values are statistically significant. T is reported as percentage of patients and their corresponding results. HLA-A2 Major Histocom
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL HER-2/neu Peptide Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-05 |
| Est. Completion | 2023-05-22 |
| Phase | Phase 1 |
What the finished NCT00194714 record still lists
NCT00194714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00194714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00194714 about?
NCT00194714 is a clinical study titled "Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab". This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving tra...
What is the current status of trial NCT00194714?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2016-05. Estimated completion is 2023-05-22.
What interventions are being tested in trial NCT00194714?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), HER-2/neu Peptide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00194714?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00194714's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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