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NCT00394251 · ClinicalTrials.gov registry record · Phase 2
Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
NCT00394251: Completed Phase 2 study, sponsored by Celgene.
NCT00394251 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 197 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00394251, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
Study Summary
The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.
Primary Outcome
Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of \>=20% in any treatment arm, and participants with at least one toxicity are reported. Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment
Interventions
- DRUG Bevacizumab
- DRUG pegfilgrastim
- DRUG Taxol
- DRUG ABI-007
- DRUG Adriamycin and Cytoxan (AC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2006-08-01 |
| Est. Completion | 2008-02-01 |
| Phase | Phase 2 |
What the finished NCT00394251 record still lists
NCT00394251 is an interventional study that assigns participants to a tested intervention. The registered 197 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 (48% higher).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT00394251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00394251 about?
NCT00394251 is a clinical study titled "Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer". The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then...
What is the current status of trial NCT00394251?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2006-08-01. Estimated completion is 2008-02-01.
What interventions are being tested in trial NCT00394251?
The interventions under investigation include: Bevacizumab (DRUG), pegfilgrastim (DRUG), Taxol (DRUG), ABI-007 (DRUG), Adriamycin and Cytoxan (AC) (DRUG).
Who is sponsoring clinical trial NCT00394251?
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 NCT00394251's enrollment target sits among peer trials
197 349th of 2000 higher than 1,652 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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