Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant
- Registration Number
- NCT01019577
- Lead Sponsor
- R-Pharm
- Brief Summary
The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 54
Inclusion Criteria
- Women aged 20 years or older
- Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination
Exclusion Criteria
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ixabepilone Ixabepilone -
- Primary Outcome Measures
Name Time Method To assess the tumor response using RECIST Criteria to determine the best overall response and response rate For a maximum of 9 3-week cycles or until unacceptable toxicity
- Secondary Outcome Measures
Name Time Method To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria Every cycle To evaluate the duration of achieved responses For a maximum of 9 3-week cycles or until unacceptable toxicity To evaluate time to progression (TTP) For a maximum of 9 3-week cycles or until unacceptable toxicity