Trial Condition(s):

Breast Neoplasm

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

Bayer Identifier:

91466

ClinicalTrials.gov Identifier:

NCT00313248

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
65
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

M. D. Anderson Cancer Center - University of Texas

Houston, United States, 77030

Status
Completed
 
Locations

Cancer Care Center, Inc.

New Albany, United States, 47150

Status
Completed
 
Locations

University of Alabama at Birmingham

Birmingham, United States, 35233

Status
Completed
 
Locations

Georgetown University Medical Center

Washington, United States, 20007

Status
Completed
 
Locations

Genesis Cancer Center

Hot Springs, United States, 71913

Status
Completed
 
Locations

Hopital du St-Sacrement

Quebec, Canada, G1S 4L8

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Greater Baltimore Medical Center

Baltimore, United States, 21204

Status
Completed
 
Locations

Halifax Health Medical Center

Daytona Beach, United States, 32114

Status
Terminated
 
Locations

Tacoma General Hospital

Tacoma, United States, 98405

Status
Completed
 
Locations

Comprehensive Blood and Cancer Center

Bakersfield, United States, 93309

Status
Completed
 
Locations

Comprehensive Cancer Center

Palm Springs, United States, 92262

Status
Completed
 
Locations

Weill Cornell Breast Center

New York, United States, 10021

Status
Completed
 
Locations

South Texas Oncology & Hematology, P.A.

San Antonio, United States, 78207

Status
Completed
 
Locations

Alaska Cancer Research and Education Center

Anchorage, United States, 99508

Status
Completed
 
Locations

Saint Barnabas Medical Center

Livingston, United States, 07039

Status
Completed
 
Locations

Oregon Health and Science University

Portland, United States, 97239

Status
Completed
 
Locations

SUNY Upstate Medical University

Syracuse, United States, 13210

Status
Terminated
 
Locations

University of Colorado Hospital

Aurora, United States, 80010

Status
Completed
 
Locations

Magee Womens Hospital of UPMC

Pittsburgh, United States, 15213-3180

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

University of Minnesota Physicians

Minneapolis, United States, 55455

Status
Completed
 
Locations

Hopital Charles LeMoyne

Greenfield Park, Canada, J4V 2H1

Status
Terminated
 
Locations

University of Arizona Cancer Center

Tucson, United States, 85724

Status
Terminated
 
Locations

Cancer Care Specialists of Central Illinois

Decatur, United States, 62526

Status
Completed
 

Trial Design