Phase II 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
Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer
Female
Metastatic Breast Cancer
Trial Information
Phase II 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
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:
To assess the tumor response using RECIST Criteria to determine the best overall response and response rate
Outcome Time Frame:
For a maximum of 9 3-week cycles or until 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:
CA163-107
NCT ID:
NCT01019577
Start Date:
October 2005
Completion Date:
July 2007
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms
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