Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
NCT ID: NCT00313248
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2006-04-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Sagopilone (ZK 219477)
All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
Arm 2
Sagopilone (ZK 219477)
Patients will receive 22mg/m2 as intravenous infusion.
Interventions
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Sagopilone (ZK 219477)
All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
Sagopilone (ZK 219477)
Patients will receive 22mg/m2 as intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Anchorage, Alaska, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Bakersfield, California, United States
Palm Springs, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Daytona Beach, Florida, United States
Decatur, Illinois, United States
New Albany, Indiana, United States
Baltimore, Maryland, United States
Minneapolis, Minnesota, United States
Livingston, New Jersey, United States
New York, New York, United States
Syracuse, New York, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tacoma, Washington, United States
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Countries
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References
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Morrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10.
Other Identifiers
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307975
Identifier Type: OTHER
Identifier Source: secondary_id
91466
Identifier Type: -
Identifier Source: org_study_id