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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 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 113 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00915603
The ClinicalTrials.gov registry entry for NCT00915603 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00915603 reports 0 study locations.
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.
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