NCT00546364

Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer

IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
DRUG	Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2	Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
DRUG	Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2	Docetaxel 75 mg/m\^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-10-18
• Last updated: 2016-03-10
• Results posted: 2011-06-01

Locations

60 sites across 1 country: United States