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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 InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionBurlington, Vermont  
Local InstitutionVancouver, Washington  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionLincoln, Nebraska  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionAlbuquerque, New Mexico  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionChattanooga, Tennessee  
Local InstitutionSalt Lake City, Utah  
Local InstitutionLittle Rock, Arkansas  
Local InstitutionJackson, Mississippi  
Local InstitutionColumbia, Missouri  
Local InstitutionMorgantown, West Virginia