Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 26, 2004

Last Updated Date

October 9, 2008

Start Date ^†

September 2003

Current Primary Outcome Measures ^†

Time to Progression [ Time Frame: Until progression/unacceptable toxicity ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00080301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Survival [ Time Frame: Until death ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Breast Cancer
Metastases

Intervention ^†

Drug: Ixabepilone + Capecitabine
Drug: Capecitabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

752

Completion Date

March 2008

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy (At least one regimen given in the metastatic setting).
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)

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

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

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00080301

Responsible Party

Study Director, Bristol-Myers Squibb

Secondary IDs ^††

Study Sponsor ^†

Bristol-Myers Squibb

Collaborators ^††

Investigators ^†

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.