Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
Ixabepilone
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.125 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 45 locations
Local Institution
Meriden, United StatesLocal Institution
Jacksonville, United StatesLocal Institution
Baltimore, United States