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

Phase 2

Completed

• Conditions: Breast Cancer; Metastases
• Interventions: Drug: Ixabepilone

• Registration Number: NCT00080262
• Lead Sponsor: R-Pharm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-03-25
• Study First Submitted QC: 2004-03-25
• Study First Posted: 2004-03-26
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ixabepilone	-

Primary Outcome Measures

Name	Time	Method
Response rate as determined by the IRRC

Secondary Outcome Measures

Name	Time	Method
Time to progression, duration of response, overall survival

Trial Locations

Locations (1)

Local Institution; 🇸🇪 Stockholm, Sweden