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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: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00121836 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 109 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00121836 record still lists
NCT00121836 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00121836 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00121836's enrollment target sits among peer trials
109 737th of 2000 higher than 1,261 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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