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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastases

Thank you

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