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
18 Years
N/A
Female
Breast Cancer, Metastases
Trial Information
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
Inclusion Criteria
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
Outcome Description:
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.
Outcome Time Frame:
based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA163-046
NCT ID:
NCT00080301
Start Date:
September 2003
Completion Date:
March 2008
Related Keywords:
- Breast Cancer
- Metastases
- Metastatic Breast Cancer
- Breast Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Local Institution | Baltimore, Maryland |
| Local Institution | Bronx, New York |
| Local Institution | Cincinnati, Ohio |
| Local Institution | Burlington, Vermont |
| Local Institution | Vancouver, Washington |
| Local Institution | Corona, California |
| Local Institution | Aurora, Colorado |
| Local Institution | Hamden, Connecticut |
| Local Institution | Washington, District of Columbia |
| Local Institution | Fort Lauderdale, Florida |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Lincoln, Nebraska |
| Local Institution | New Brunswick, New Jersey |
| Local Institution | Albuquerque, New Mexico |
| Local Institution | Oklahoma City, Oklahoma |
| Local Institution | Duncansville, Pennsylvania |
| Local Institution | North Charleston, South Carolina |
| Local Institution | Austin, Texas |
| Local Institution | Chattanooga, Tennessee |
| Local Institution | Salt Lake City, Utah |
| Local Institution | Little Rock, Arkansas |
| Local Institution | Jackson, Mississippi |
| Local Institution | Columbia, Missouri |
| Local Institution | Morgantown, West Virginia |
