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NCT00364611 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT00364611 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 73 participants.
The verdict
NCT00364611, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT). All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.
Interventions
- DRUG Trastuzumab
- DRUG Bevacizumab
- DRUG Docetaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00364611
The ClinicalTrials.gov registry entry for NCT00364611 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT00364611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00364611 about?
NCT00364611 is a clinical study titled "Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer". Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according...
What is the current status of trial NCT00364611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2006-08. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00364611?
The interventions under investigation include: Trastuzumab (DRUG), Bevacizumab (DRUG), Docetaxel (DRUG).
Who is sponsoring clinical trial NCT00364611?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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