Clinical trial NCT00080262: Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)
Official title: Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastases
Keywords: Metastatic Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2004-03-26
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Response rate as determined by the IRRC
Secondary outcomes:
measure: Time to progression, duration of response, overall survival
Other outcomes:
Locations:
city: La Verne
country: United States
facility: Local Institution
state: California
city: Meriden
country: United States
facility: Local Institution
state: Connecticut
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: New York
country: United States
facility: Local Institution
state: New York
city: Asheville
country: United States
facility: Local Institution
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Chattanooga
country: United States
facility: Local Institution
state: Tennessee
city: Jackson
country: United States
facility: Local Institution
state: Tennessee
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Houston
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Besancon Cedex
country: France
facility: Local Institution
city: Bobigny
country: France
facility: Local Institution
city: Clermont-Ferrand
country: France
facility: Local Institution
city: Dijon Cedex
country: France
facility: Local Institution
city: Lyon
country: France
facility: Local Institution
city: Marseille Cedex 9
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Frankfurt Hoechst
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Chihuahua
country: Mexico
facility: Local Institution
city: Distrito Federal
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Trondheim
country: Norway
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Fichardtpark
country: South Africa
facility: Local Institution
state: Free State
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Overport
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Panorama
country: South Africa
facility: Local Institution
state: Western Cape
city: Helsingborg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Malmo
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.