The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
Patients will receive 22mg/m2 as intravenous infusion.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Anchorage, Alaska, United States
Response to treatment with ZK-Epo after 6 cycles
Time frame: complete or partial response after 2 to 6 courses of therapy.
Safety and tolerability of ZK-Epo
Time frame: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.
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Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Palm Springs, California, United States
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Aurora, Colorado, United States
Unnamed facility
Washington D.C., District of Columbia, United States
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Daytona Beach, Florida, United States
Unnamed facility
Decatur, Illinois, United States
...and 15 more locations