Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00080262
First received: March 25, 2004
Last updated: April 7, 2011
Last verified: April 2011

March 25, 2004
April 7, 2011
February 2004
December 2006   (final data collection date for primary outcome measure)
Response rate as determined by the IRRC
Not Provided
Complete list of historical versions of study NCT00080262 on ClinicalTrials.gov Archive Site
Time to progression, duration of response, overall survival
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Metastases
Drug: Ixabepilone
Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
Other Name: BMS-247550
Experimental: 1
Intervention: Drug: Ixabepilone
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. Epub 2007 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   France,   Germany,   Mexico,   Netherlands,   Norway,   South Africa,   Sweden
 
NCT00080262
CA163-081
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

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