A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer



Status:Archived
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2009
End Date:September 2014

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A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer


The purpose of this study is to evaluate survival, response rate, safety and tolerability of
YM155 given in combination with docetaxel as first-line treatment in subjects with human
epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.


This is an outpatient study. All subjects enrolled in this study will receive a combined
regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject
will be assessed at the end of each cycle to determine if the subject can continue to the
next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be
eligible to continue receiving the combination regimen in this study until one of the
discontinuation criteria is met.

If a subject discontinues treatment with at least stable disease (SD) that subject will
complete follow-up visits every 12 weeks for 2 years or until initiating another systemic
anti-breast cancer treatment, exhibiting progressive disease (PD), or death.

Each subject will be contacted by the study site every 12 weeks for survival following the
End of Treatment Visit. The contacts will continue until death or for no more than 2 years.


We found this trial at
11
sites
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Lima, OH
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Albuquerque, New Mexico
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Albuquerque, NM
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Austin, Texas
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Austin, TX
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Birmingham, Alabama
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Birmingham, AL
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Celebration, Florida
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Celebration, FL
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Charlotte, North Carolina
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Charlotte, NC
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Detroit, Michigan
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Detroit, MI
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Great Falls, Montana 59405
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Great Falls, MT
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Mountlake Terrace, Washington
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Mountlake Terrace, WA
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Santa Clara, California 95051
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Santa Clara, CA
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