CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,221 enrolled
Drug / intervention
Ixabepilone + Capecitabine +1 moredrug
Likely dose
Ixabepilone 40 mg/m² IV on Day 1 + Capecitabine 2000 mg/m² oral twice daily Days 1-14 of 21-day cycleAI-extracted
Key inclusion· 2
  • ✓Advanced/metastatic breast cancer previously treated with both an anthracycline and a taxane
  • ✓No more than two prior chemotherapy regimens; if no prior metastatic treatment, must have relapsed within one year
Key exclusion· 3
  • ✕Any history of brain and/or leptomeningeal metastases
  • ✕Grade 2 or worse peripheral neuropathy at study entry
  • ✕Prior treatment with epothilones and/or capecitabine

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00082433
NCT00082433Phase 3Completed
CompareCT.gov

A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

R-Pharm·interventional·Posted May 11, 2004·Updated Nov 2, 2020

In Brief

A Phase 3 clinical trial evaluating Ixabepilone + Capecitabine and Capecitabine for Cancer and Breast Cancer. Completed, enrolled 1,221 participants across 186 sites in 29 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Breast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2004
Enrollment StartNov 1, 2003
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 22.1 years ago

Interventions

Ixabepilone + Capecitabinedrug

Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle

Capecitabinedrug

Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle