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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 470 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00077857
The ClinicalTrials.gov registry entry for NCT00077857 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 470 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 docetaxel (Taxotere®) is the first listed.
NCT00077857 reports 0 study locations.
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.
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