| Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer |
| 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 |
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. |
|
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Overall Survival from Date of Randomization to Death [ Time Frame: at end of study ] [ Designated as safety issue: No ] |
Time To Progression [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Response Rate and Duration of Response in patients with Measureable disease [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: at end of study ] [ Designated as safety issue: No ] |
Cancer
Breast Cancer |
Drug: Ixabepilone + Capecitabine
Drug: Capecitabine |
|
BMS Clinical Trials Disclosure 
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  |
|
| Completed |
| 1220 |
| November 2003 |
| April 2008 |
- Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
- Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.
- Patients may not have any history of brain and/or leptomeningeal metastases.
- Patients may not have Grade 2 or worse neuropathy at the time of study entry.
- Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)
|
| Female |
| 18 Years and older |
| No |
|
| United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Netherlands, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom |
|
| NCT00082433 |
| CA163-048 |
|
| Bristol-Myers Squibb |
|
| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
|
|
| Bristol-Myers Squibb |
| October 2008 |
| May 7, 2004 |
| October 9, 2008 |