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NCT00281528 · ClinicalTrials.gov registry record · Phase 2
Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer
A Phase 2 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 2
- Development phase
- 208
- Enrollment target
NCT00281528: Clinical Trial Phase 2 study, sponsored by Celgene.
NCT00281528 is a Phase 2 study that was terminated before completion, run by Celgene. The registered enrollment target is 208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00281528, a Phase 2 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 208 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.
Primary Outcome
Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall
Interventions
- DRUG bevacizumab
- DRUG ABI-007 (Abraxane)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2006-02-01 |
| Est. Completion | 2011-03-01 |
| Phase | Phase 2 |
Why NCT00281528 stopped before completion
NCT00281528 is an interventional study that assigns participants to a tested intervention. The registered 208 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 (56% higher).
The record links to 0 conditions, and to 2 interventions - of which bevacizumab is the first listed.
NCT00281528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00281528 about?
NCT00281528 is a clinical study titled "Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer". This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also re...
What is the current status of trial NCT00281528?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2006-02-01. Estimated completion is 2011-03-01.
What interventions are being tested in trial NCT00281528?
The interventions under investigation include: bevacizumab (DRUG), ABI-007 (Abraxane) (DRUG).
Who is sponsoring clinical trial NCT00281528?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00281528's enrollment target sits among peer trials
208 294th of 2000 higher than 1,704 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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