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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.

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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

FieldValue
Enrollment Target 1,221 participants
Start Date 2003-11
Est. Completion 2008-03
Phase Phase 3
R-Pharm

19 total trials

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.

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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00082433, the US trial registry maintained by the National Library of Medicine. NCT00082433 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.