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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Drug: Sagopilone (ZK 219477)
* Drug: Sagopilone (ZK 219477)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sagopilone (ZK 219477)<br>* All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.<br>* Other names: BAY86-5302;|
| Experimental: Arm 2<br> | Drug: Sagopilone (ZK 219477)<br>* Patients will receive 22mg/m2 as intravenous infusion.<br>* Other names: BAY86-5302;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment with ZK-Epo after 6 cycles |  | complete or partial response after 2 to 6 courses of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Metastatic Breast Cancer