Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer - Tabular View

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Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

This study has been completed.

Study NCT00082433. Last updated on October 9, 2008. Information provided by Bristol-Myers Squibb

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

Descriptive Information Fields

Brief Title ^†

Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Official Title ^†

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

Brief Summary

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. 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

Primary Outcome Measure ^†

Overall Survival from Date of Randomization to Death [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Time To Progression [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Response Rate and Duration of Response in patients with Measureable disease [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Condition ^†

Cancer
Breast Cancer

Intervention ^†

Drug: Ixabepilone + Capecitabine
Drug: Capecitabine

MEDLINE PMIDs

Links

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1220

Start Date ^†

November 2003

Completion Date

April 2008

Eligibility 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)

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Netherlands, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00082433

Organization ID

CA163-048

Secondary IDs ^††

Study Sponsor ^†

Bristol-Myers Squibb

Collaborators ^††

Investigators ^†

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2008

First Received Date ^†

May 7, 2004

Last Updated Date

October 9, 2008

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