A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant

NCT00080301 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	R-Pharm
Phase	Phase 3
Status	COMPLETED
Enrolment	752
Start date	2003-09
Completion	2008-03

Conditions

• Breast Cancer
• Metastases

Interventions

• Ixabepilone + Capecitabine
• Capecitabine

Primary outcomes

• Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC) — based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
  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.

Countries

United States, Argentina, Belgium, Brazil, Canada, China, France, Germany, Greece, Hungary, Italy, Malaysia, Mexico, Peru, Philippines, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom