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NCT00089479 · ClinicalTrials.gov registry record · Phase 3
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,611
- Enrollment target
NCT00089479: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00089479 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 2,611 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (238% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089479, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,611 participants
- Enrollment target
Study Summary
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Primary Outcome
Number of patients with/without recurrence of breast cancer, or death due to any cause.
Interventions
- DRUG Taxotere
- DRUG capecitabine [Xeloda]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,611 participants |
| Start Date | 2002-08 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00089479 record still lists
NCT00089479 is an interventional study that assigns participants to a tested intervention. Its 2,611 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (238% higher).
The record links to 0 conditions, and to 2 interventions - of which Taxotere is the first listed.
NCT00089479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00089479 about?
NCT00089479 is a clinical study titled "A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer". This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv o...
What is the current status of trial NCT00089479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,611 participants. The study started on 2002-08. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00089479?
The interventions under investigation include: Taxotere (DRUG), capecitabine [Xeloda] (DRUG).
Who is sponsoring clinical trial NCT00089479?
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 NCT00089479's enrollment target sits among peer trials
2,611 84th of 2000 higher than 1,917 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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