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NCT00121836 · ClinicalTrials.gov registry record · Phase 4
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 109
- Enrollment target
NCT00121836 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 109 participants.
The verdict
NCT00121836, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 109 participants
- Enrollment target
Study Summary
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121836
The ClinicalTrials.gov registry entry for NCT00121836 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 109 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 2 interventions - of which Bevacizumab is the first listed.
NCT00121836 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00121836 about?
NCT00121836 is a clinical study titled "A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer". This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1...
What is the current status of trial NCT00121836?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 109 participants. The study started on 2005-06. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00121836?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00121836?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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