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NCT00524277 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy in Treating Patients With Breast Cancer
A Phase 2 study, sponsored by San Antonio Military Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 456
- Enrollment target
NCT00524277: Completed Phase 2 study, sponsored by San Antonio Military Medical Center.
NCT00524277 is a Phase 2 study that has completed, run by San Antonio Military Medical Center. The registered enrollment target is 456 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (243% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00524277, a Phase 2 study, has completed, sponsored by San Antonio Military Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 456 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer. PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.
Primary Outcome
The following will be compared: 1. disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone 2. disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone 3. disease recurrence rates between all four arms of the trial.
Interventions
- BIOLOGICAL GP2 peptide + GM-CSF vaccine
- BIOLOGICAL GM-CSF (sargramostim)
- BIOLOGICAL AE37 + GM-CSF vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2007-01 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 2 |
What the finished NCT00524277 record still lists
NCT00524277 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (243% higher).
The record links to 0 conditions, and to 3 interventions - of which GP2 peptide + GM-CSF vaccine is the first listed.
NCT00524277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00524277 about?
NCT00524277 is a clinical study titled "Vaccine Therapy in Treating Patients With Breast Cancer". RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therap...
What is the current status of trial NCT00524277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 456 participants. The study started on 2007-01. Estimated completion is 2017-03-31.
What interventions are being tested in trial NCT00524277?
The interventions under investigation include: GP2 peptide + GM-CSF vaccine (BIOLOGICAL), GM-CSF (sargramostim) (BIOLOGICAL), AE37 + GM-CSF vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00524277?
This trial is sponsored by San Antonio Military Medical Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00524277's enrollment target sits among peer trials
456 84th of 2000 higher than 1,916 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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