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Brief Title: BMS-247550 in Treating Women With Metastatic Breast Cancer
Official Title: A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer
Study ID: NCT00020904
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.
Detailed Description: OBJECTIVES: * Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer. * Determine the safety of this drug in these patients. * Determine the duration of response, time to progression, and survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Name: Clifford A. Hudis, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR