Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)
Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
1 other identifier
interventional
125
10 countries
45
Brief Summary
The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Feb 2004
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 25, 2004
CompletedFirst Posted
Study publicly available on registry
March 26, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 30, 2017
January 1, 2017
2.8 years
March 25, 2004
January 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate as determined by the IRRC
Secondary Outcomes (1)
Time to progression, duration of response, overall survival
Study Arms (1)
1
EXPERIMENTALInterventions
Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
Eligibility Criteria
You may qualify if:
- Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant
- No more than 3 prior chemotherapy regimens in the metastatic setting
- Must have at least one target lesion that is radiographically measurable
- Good performance status
- No history of or current brain or leptomeningeal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Pharmlead
Study Sites (45)
Local Institution
La Verne, California, United States
Local Institution
Meriden, Connecticut, United States
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Jacksonville, Florida, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Chattanooga, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Buenos Aires, Argentina
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Santa Fe, Argentina
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Montreal, Quebec, Canada
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Besançon, France
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Bobigny, France
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Clermont-Ferrand, France
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Dijon, France
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Lyon, France
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Marseille, France
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Vandœuvre-lès-Nancy, France
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Frankfurt, Germany
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Frankfurt Hoechst, Germany
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Mérida, Yucatán, Mexico
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Chihuahua City, Mexico
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Distrito Federal, Mexico
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Amsterdam, Netherlands
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Leiden, Netherlands
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Oslo, Norway
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Trondheim, Norway
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Port Elizabeth, Eastern Cape, South Africa
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Fichardtpark, Free State, South Africa
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Pretoria, Gauteng, South Africa
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Overport, KwaZulu-Natal, South Africa
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Panorama, Western Cape, South Africa
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Helsingborg, Sweden
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Lund, Sweden
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Malmo, Sweden
Local Institution
Stockholm, Sweden
Related Publications (1)
Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14. doi: 10.1200/JCO.2006.09.3849. Epub 2007 Jul 2.
PMID: 17606974BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 25, 2004
First Posted
March 26, 2004
Study Start
February 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 30, 2017
Record last verified: 2017-01