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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Epothilones; Sagopilone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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