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NCT00082433 · ClinicalTrials.gov registry record · Phase 3
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
A Phase 3 study of Breast Cancer and Cancer, sponsored by R-Pharm.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,221
- Enrollment target
- 20
- Study locations
NCT00082433: Completed Phase 3 study of Breast Cancer and Cancer, sponsored by R-Pharm.
NCT00082433 is a Phase 3 study of Breast Cancer and Cancer that has completed, run by R-Pharm. The registered enrollment target is 1,221 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00082433, a Phase 3 study of Breast Cancer and Cancer, has completed, sponsored by R-Pharm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,221 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.
Primary Outcome
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Ixabepilone + Capecitabine
Study Locations (20)
New York
- Local Institution - Latham
- Local Institution - Mineola
- Local Institution - New York
- Local Institution - The Bronx
California
- Local Institution - Beverly Hills
- Local Institution - Corona
Arizona
- Local Institution - Tucson
Connecticut
- Local Institution - Hartford
Florida
- Local Institution - Plantation
Idaho
- Local Institution - Boise
Illinois
- Local Institution - Evanston
Iowa
- Local Institution - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,221 participants |
| Start Date | 2003-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00082433 record still lists
NCT00082433 is an interventional study that assigns participants to a tested intervention. Its 1,221 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.
NCT00082433 names 20 study sites across 16 states, led by New York, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00082433 about?
NCT00082433 is a clinical study titled "Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer". The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. T...
What is the current status of trial NCT00082433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,221 participants. The study started on 2003-11. Estimated completion is 2008-03.
What conditions does trial NCT00082433 study?
This clinical trial studies the following conditions: Breast Cancer, Cancer.
What interventions are being tested in trial NCT00082433?
The interventions under investigation include: Capecitabine (DRUG), Ixabepilone + Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00082433?
This trial is sponsored by R-Pharm, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00082433 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00082433's enrollment target sits among peer trials
1,221 104th of 1224 higher than 1,121 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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