| March 26, 2004 |
| July 2, 2009 |
| September 2003 |
| November 2006 (final data collection date for primary outcome measure) |
| Progression-Free Survival (PFS) Per Independent Radiology Review Committee (IRRC) [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ] |
| Time to Progression |
| Complete list of historical versions of study NCT00080301 on ClinicalTrials.gov Archive Site |
- Overall Response Rate (ORR) Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ]
- Duration of Response Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ]
- Time to Response Per IRRC [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: from date of randomization until death ] [ 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 ]
|
| Survival |
| |
| Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
|
|
- Drug: Ixabepilone + Capecitabine
- Drug: Capecitabine
|
| |
| |
| |
| Completed |
| 752 |
| March 2008 |
| November 2006 (final data collection date for primary outcome measure) |
- Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
- Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
- Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
- Patients must be resistant to taxane therapy.
- Patients may not have any history of brain and/or leptomeningeal metastases.
- Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
- Patients may have not have had prior treatment with an epothilone 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, Belgium, Brazil, Canada, China, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Spain, Sweden, Taiwan, Thailand, United Kingdom |
| |
| NCT00080301 |
| Study Director, Bristol-Myers Squibb |
| CA163-046 |
| Bristol-Myers Squibb |
|
| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
|
|
| Bristol-Myers Squibb |
| July 2009 |
