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

Purpose

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.

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

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Ixabepilone Capecitabine

U.S. FDA Resources

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

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	752
Study Start Date:	September 2003
Study Completion Date:	March 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Ixabepilone + Capecitabine Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
B: Active Comparator	Drug: Capecitabine Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Eligibility

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080301

Show 154 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-046
First Received:	March 26, 2004
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00080301
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Metastatic Breast Cancer

Study placed in the following topic categories:

Capecitabine

Skin Diseases

Epothilones

Neoplasm Metastasis

Breast Neoplasms

Taxane

Breast Diseases

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Mitosis Modulators

Antimitotic Agents

Pharmacologic Actions

Neoplasms

Neoplastic Processes

Neoplasms by Site

Pathologic Processes

Therapeutic Uses

Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00080301