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NCT00050167 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 603
- Enrollment target
NCT00050167: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00050167 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 603 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (905% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00050167, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 603 participants
- Enrollment target
Study Summary
Primary Objectives: * Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. * Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. * Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).
Primary Outcome
Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).
Interventions
- DRUG Docetaxel
- DRUG Capecitabine
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 603 participants |
| Start Date | 2002-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT00050167 record still lists
NCT00050167 is an interventional study that assigns participants to a tested intervention. The registered 603 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (905% higher).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00050167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00050167 about?
NCT00050167 is a clinical study titled "Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer". Primary Objectives: * Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. * Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly pa...
What is the current status of trial NCT00050167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 603 participants. The study started on 2002-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00050167?
The interventions under investigation include: Docetaxel (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00050167?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00050167's enrollment target sits among peer trials
603 27th of 2000 higher than 1,974 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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