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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


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

Thank you

Trial Information

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

Inclusion Criteria


- 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)

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:

Overall Survival (OS)

Outcome Time Frame:

from date of randomization until death

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:

CA163-048

NCT ID:

NCT00082433

Start Date:

November 2003

Completion Date:

March 2008

Related Keywords:

  • Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Local Institution Chicago, Illinois  
Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Green Bay, Wisconsin  
Local Institution Phoenix, Arizona  
Local Institution Corona, California  
Local Institution Hamden, Connecticut  
Local Institution Fort Lauderdale, Florida  
Local Institution Springfield, Massachusetts  
Local Institution New Brunswick, New Jersey  
Local Institution Albuquerque, New Mexico  
Local Institution Wilmington, North Carolina  
Local Institution Duncansville, Pennsylvania  
Local Institution Austin, Texas  
Local Institution Arlington, Virginia  
Local Institution New Orleans, Louisiana  
Local Institution Chattanooga, Tennessee  
Local Institution Jackson, Mississippi  
Local Institution Columbia, Missouri  
Local Institution Boise, Idaho  
Local Institution Iowa City, Iowa  
Local Institution Louisville, Kentucky