Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00080301 · ClinicalTrials.gov registry record · Phase 3
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
A Phase 3 study, sponsored by R-Pharm.
- Completed
- Registry status
- Phase 3
- Development phase
- 752
- Enrollment target
NCT00080301: Completed Phase 3 study, sponsored by R-Pharm.
NCT00080301 is a Phase 3 study that has completed, run by R-Pharm. The registered enrollment target is 752 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00080301, a Phase 3 study, has completed, sponsored by R-Pharm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 752 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.
Primary Outcome
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Interventions
- DRUG Capecitabine
- DRUG Ixabepilone + Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2003-09 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00080301 record still lists
NCT00080301 is an interventional study that assigns participants to a tested intervention. The registered 752 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00080301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00080301 about?
NCT00080301 is a clinical study titled "Novel Epothilone 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 is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemoth...
What is the current status of trial NCT00080301?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 752 participants. The study started on 2003-09. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00080301?
The interventions under investigation include: Capecitabine (DRUG), Ixabepilone + Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00080301?
This trial is sponsored by R-Pharm, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00080301's enrollment target sits among peer trials
752 460th of 2000 higher than 1,539 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06559306 · 752 participants · Phase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
- NCT05379985 · 754 participants · Phase 1
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
- NCT05427370 · 754 participants · NA
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
- NCT02048332 · 750 participants · Phase 1
Donor-Derived Viral Specific T-cells (VSTs)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia