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

Tracking Information

First Received Date ^ICMJE

May 7, 2004

Last Updated Date

November 16, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall Survival (OS) [ Time Frame: from date of randomization until death ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Overall Survival from Date of Randomization to Death

Change History

Complete list of historical versions of study NCT00082433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression-Free Survival (PFS) [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
Response Rate (RR) [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
Time to Response [ Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression ] [ Designated as safety issue: No ]
Treatment-Related Safety Summary [ Time Frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ] [ Designated as safety issue: Yes ]
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) [ Time Frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Time To Progression; Response Rate and Duration of Response in patients with Measureable disease; Quality of Life

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Cancer
Breast Cancer

Intervention ^ICMJE

Drug: Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
Other Names:
- IXEMPRA®
- Epothilone
Drug: Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Study Arms / Comparison Groups

A: Experimental
Intervention: Drug: Ixabepilone + Capecitabine
B: Active Comparator
Intervention: Drug: Capecitabine

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 ^ICMJE

Completed

Enrollment ^ICMJE

1221

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

NCT ID ^ICMJE

NCT00082433

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CA163-048

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP