| May 7, 2004 |
| July 2, 2009 |
| November 2003 |
| March 2008 (final data collection date for primary outcome measure) |
| Overall Survival (OS) [ Time Frame: from date of randomization until death ] [ Designated as safety issue: No ] |
| Overall Survival from Date of Randomization to Death |
| Complete list of historical versions of study NCT00082433 on ClinicalTrials.gov Archive Site |
- Progression-Free Survival (PFS) [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
- Response Rate (RR) [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
- Time to Response [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
- Treatment-Related Safety Summary [ Time Frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ] [ Designated as safety issue: Yes ]
- Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) [ Time Frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment ] [ Designated as safety issue: No ]
|
| Time To Progression; Response Rate and Duration of Response in patients with Measureable disease; Quality of Life |
| |
| 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 |
|
|
- Drug: Ixabepilone + Capecitabine
- Drug: Capecitabine
|
| |
| |
| |
| Completed |
| 1221 |
| March 2008 |
| March 2008 (final data collection date for primary outcome measure) |
- 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 |
| Contact information is only displayed when the study is recruiting subjects |
| 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 |
| Study Director, Bristol-Myers Squibb |
| CA163-048 |
| Bristol-Myers Squibb |
|
| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
|
|
| Bristol-Myers Squibb |
| July 2009 |
