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NCT00733408 · ClinicalTrials.gov registry record · Phase 2
Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00733408: Completed Phase 2 study, sponsored by University of Washington.
NCT00733408 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00733408, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can prevent cancer growth by blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and bevacizumab which may control cancer growth with biologic therapies.
Primary Outcome
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erl
Interventions
- DRUG paclitaxel albumin-stabilized nanoparticle formulation
- BIOLOGICAL bevacizumab
- DRUG erlotinib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2008-04-23 |
| Est. Completion | 2017-09-28 |
| Phase | Phase 2 |
What the finished NCT00733408 record still lists
NCT00733408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which paclitaxel albumin-stabilized nanoparticle formulation is the first listed.
NCT00733408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00733408 about?
NCT00733408 is a clinical study titled "Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer". This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel al...
What is the current status of trial NCT00733408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2008-04-23. Estimated completion is 2017-09-28.
What interventions are being tested in trial NCT00733408?
The interventions under investigation include: paclitaxel albumin-stabilized nanoparticle formulation (DRUG), bevacizumab (BIOLOGICAL), erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00733408?
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 NCT00733408's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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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