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NCT00821964 · ClinicalTrials.gov registry record · Phase 2
Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00821964: Completed Phase 2 study, sponsored by University of Washington.
NCT00821964 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00821964, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This phase II trial is studying the side effects of giving topical imiquimod together with Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in treating patients with advanced breast cancer. Biological therapies, such as imiquimod, may stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill more tumor cells.
Primary Outcome
Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Evaluation of target lesions per modified WHO response criteria: * Complete response (CR): complete clearance (100%) of target lesion(s) * Partial response (PR): ≥ 50% decrease in target lesion size * Stable disease (SD): \< 5
Interventions
- OTHER laboratory biomarker analysis
- DRUG Abraxane
- GENETIC RNA analysis
- DRUG imiquimod
- OTHER immunoenzyme technique
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-11-29 |
| Phase | Phase 2 |
What the finished NCT00821964 record still lists
NCT00821964 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00821964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00821964 about?
NCT00821964 is a clinical study titled "Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer". This phase II trial is studying the side effects of giving topical imiquimod together with Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in treating patients with advanced breast cancer. Biological therapies, such as imiquimod, may stimulate the immune sy...
What is the current status of trial NCT00821964?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2008-12. Estimated completion is 2012-11-29.
What interventions are being tested in trial NCT00821964?
The interventions under investigation include: laboratory biomarker analysis (OTHER), Abraxane (DRUG), RNA analysis (GENETIC), imiquimod (DRUG), immunoenzyme technique (OTHER).
Who is sponsoring clinical trial NCT00821964?
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 NCT00821964's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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