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NCT00077857 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 470
- Enrollment target
NCT00077857: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00077857 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 470 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (253% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00077857, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 470 participants
- Enrollment target
Study Summary
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\^2 or 825 mg/m\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.
Primary Outcome
Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.
Interventions
- DRUG docetaxel (Taxotere®)
- DRUG capecitabine (Xeloda®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2003-07 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00077857 record still lists
NCT00077857 is an interventional study that assigns participants to a tested intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (253% higher).
The record links to 0 conditions, and to 2 interventions - of which docetaxel (Taxotere®) is the first listed.
NCT00077857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00077857 about?
NCT00077857 is a clinical study titled "A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer". This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to recei...
What is the current status of trial NCT00077857?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 470 participants. The study started on 2003-07. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00077857?
The interventions under investigation include: docetaxel (Taxotere®) (DRUG), capecitabine (Xeloda®) (DRUG).
Who is sponsoring clinical trial NCT00077857?
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 NCT00077857's enrollment target sits among peer trials
470 78th of 2000 higher than 1,921 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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