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NCT01663727 · ClinicalTrials.gov registry record · Phase 3
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 481
- Enrollment target
NCT01663727 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 481 participants.
The verdict
NCT01663727, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 481 participants
- Enrollment target
Study Summary
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.
Interventions
- DRUG Placebo
- DRUG Paclitaxel
- DRUG Bevacizumab [Avastin]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2012-08-27 |
| Est. Completion | 2017-11-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01663727
The ClinicalTrials.gov registry entry for NCT01663727 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 481 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01663727 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01663727 about?
NCT01663727 is a clinical study titled "Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer". This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be ran...
What is the current status of trial NCT01663727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2012-08-27. Estimated completion is 2017-11-21.
What interventions are being tested in trial NCT01663727?
The interventions under investigation include: Placebo (DRUG), Paclitaxel (DRUG), Bevacizumab [Avastin] (DRUG).
Who is sponsoring clinical trial NCT01663727?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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