None listed
Conditions
Interventions
Ixabepilone + Capecitabine Type of group
Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity
Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Group name:Capecitabine Type of group
Capecitabine Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: Histological or cytological diagnosis of adenocarcinoma of mammary origin. Evidence that the cancer is metastatic or locally advanced, and is not curable using local measures, for example, surgery or radiation. Measurable disease, defined by at least one lesion that can be measured in one dimension (RECIST criteria) and that has not been subjected to radiation. Patients who have been treated with trastuzumab should have discontinued the therapy before enrolling in the study. Performance status in the Karnofsky score between 70 and 100. Life expectancy of at least 12 months.
Exclusion criteria
Exclusion criteria: Any history of brain and / or leptomeningeal metastasis. MEF that are not willing or able to use a method of birth control that is acceptable throughout the study and for a period of up to 4 weeks after the end of the study. Serious intercurrent infections, or non-malignant diseases that are not controlled or whose control may be jeopardized by the complications of this therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The time to progression for all patients. The tumor response will be evaluated using the RECIST criteria. The response rate, the time to response, the duration of the response and the overall survival will be evaluated as secondary end points of effectiveness. Patients will be evaluated for safety if they received a study drug. Measure:The time to progression for BMS-247550 plus capecitabine versus capecitabine as a single agent, in patients with advanced breast cancer previously treated with, or resistant to, an anthracycline, and showing resistance to taxanes. Timepoints:21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Global survival using BMS-247550 plus capecitabine versus capecitabine. Measure:Compare in this population of patients the global survival using BMS-247550 plus capecitabine versus capecitabine as a single agent. Timepoints:21 days | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Hungary, Italy, Mexico, Peru, Philippines, Poland, Spain, Sweden, Taiwan, Thailand, United Kindgdom, United States
Outcome results
None listed