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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00082433

Purpose

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.

Condition	Intervention	Phase
Cancer Breast Cancer	Drug: Ixabepilone + Capecitabine Drug: Capecitabine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Ixabepilone

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	1221
Study Start Date:	November 2003
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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
B: Active Comparator	Drug: Capecitabine Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082433

Show 226 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Phrma website - CSR synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-048
Study First Received:	May 7, 2004
Results First Received:	May 1, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00082433 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Epothilones
Mitosis Modulators
Physiological Effects of Drugs

Breast Neoplasms
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Fluorouracil
Tubulin Modulators
Breast Diseases

ClinicalTrials.gov processed this record on November 11, 2009