Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

Completed · Phase 2

Conditions studied: Breast Neoplasm

In brief

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.

Key facts

Study ID

NCT00313248

Run by

Bayer

People needed

65

Starts

2006-04-01

Expected to finish

2008-11-01

Last updated by the study team

2015-12-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic breast cancer (meaning the cancer has spread beyond its original location)
• At least one measurable lesion by CT or MRI
• Progression of disease following previous therapy for breast cancer
• Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
• Not be pregnant
• Additional criteria to be determined at screening visit.

You may not qualify if…

• More than 3 previous chemotherapy regimens
• More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
• Prior treatment with epothilones (e.g. Ixabepilone)
• Symptomatic brain metastases
• Additional criteria to be determined at screening visit

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Anchorage, Alaska, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Palm Springs, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Decatur, Illinois, United States
• Study site — New Albany, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Livingston, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Tacoma, Washington, United States
• Study site — Toronto, Ontario, Canada
• Study site — Greenfield Park, Quebec, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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