Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
- Registration Number
- NCT00313248
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Sagopilone (ZK 219477) - Arm 2 Sagopilone (ZK 219477) -
- Primary Outcome Measures
Name Time Method Response to treatment with ZK-Epo after 6 cycles complete or partial response after 2 to 6 courses of therapy.
- Secondary Outcome Measures
Name Time Method Safety and tolerability of ZK-Epo time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.