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NCT00915603 · ClinicalTrials.gov registry record · Phase 2
Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT00915603: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT00915603 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00915603, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study Summary
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/ bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations every 8 weeks, until tumor progression or intolerable toxicity occurs. Outcomes will be assessed for each treatment arm separately. This trial is not intended to compare treatment arms primarily. Any such analyses are exploratory and will be conducted without adjustment for multiple hypothesis testing.
Primary Outcome
Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) 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
Interventions
- DRUG Bevacizumab
- DRUG Placebo
- DRUG Paclitaxel
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT00915603 record still lists
NCT00915603 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00915603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00915603 about?
NCT00915603 is a clinical study titled "Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer". This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclita...
What is the current status of trial NCT00915603?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2009-07. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00915603?
The interventions under investigation include: Bevacizumab (DRUG), Placebo (DRUG), Paclitaxel (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT00915603?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00915603's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 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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