A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
NCT ID: NCT01038804
Last Updated: 2013-09-18
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
101 participants
INTERVENTIONAL
2009-12-31
2013-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A. YM155 plus docetaxel
YM155
intravenous infusion
Docetaxel
intravenous infusion
B. docetaxel alone
Docetaxel
intravenous infusion
Interventions
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YM155
intravenous infusion
Docetaxel
intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy regimen for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
* The subject's life expectancy is estimated to be \> 12 weeks at the Baseline Visit
* The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period
Exclusion Criteria
* Neuropathy ≥ Grade 2 at the Baseline Visit
* Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
* The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
United Kingdom Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Royal Bournemouth Hospital
Poland Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Centrum Onkologii-Instytut im.
Ireland Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
St Vincent's University Hospital
Germany Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Luisenkrankenhaus Duesseldorf
Czech Republic Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Thomayer Faculty Hosptial L.G.
Belgium Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Institut Jules Bordet - Medical Oncology and Translational Research
Locations
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Kenmar Research Institute
Los Angeles, California, United States
Bay Area Cancer Research Group
Pleasant Hill, California, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Montana Cancer Institute Foundation c/o Montana Cancer Specialists
Missoula, Montana, United States
Carolina Oncology Specialists, PA
Hickory, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Institut Jules Bordet - Medical Oncology and Translational Research
Brussels, , Belgium
Grand Hopital de Charleroi - Site Notre Dame
Charleroi, , Belgium
Sint-Augustinus GZA Ziekenhuizen
Wilrijk, , Belgium
FN Kralovske Vinohrady
Prague, , Czechia
Faculty Hospital Na Bulovce
Prague, , Czechia
Hämatologisch-onkologische Praxis
Augsburg, , Germany
Frauenklinik des Universitätsklinikums Erlangen
Erlangen, , Germany
Universitatsklinikum Schleswig
Kiel, , Germany
Klinikum Mutterhaus der Borromaeerinnen
Trier, , Germany
St. Vincent's University Hospital
Dublin, , Ireland
St. James Hospital
Dublin, , Ireland
Department of Medical Oncology
Dublin, , Ireland
Centrum Onkologii-Instytut im.
Warsaw, , Poland
Wojewodzki Szpital
Wroclaw, , Poland
State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, , Russia
State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"
Kursk, , Russia
Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre
Moscow, , Russia
Pyatigorsk Oncology Dispensary
Pyatigorsk, , Russia
Scientific-Research Institute of Oncology named after Petrov
Saint Petersburg, , Russia
Saint-Petersburg State Medical University named after Pavlov
Saint Petersburg, , Russia
State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"
Samara, , Russia
Tula Regional Dispensary
Tula, , Russia
Nottingham University Hospital
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2009-012439-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
155-CL-036
Identifier Type: -
Identifier Source: org_study_id