A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone
20 Years
N/A
Female
Metastatic Breast Cancer
Trial Information
A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator
Outcome Time Frame:
21-day cycles until documented disease progression or unacceptable toxicity
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA163-130
NCT ID:
NCT01027208
Start Date:
December 2006
Completion Date:
January 2007
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
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