Spots Global Cancer Trial Database for A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
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Trial Identification
Brief Title: A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
Official Title: A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
Study ID: NCT01038804
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 10, , Czech Republic
Faculty Hospital Na Bulovce, Prague, , Czech Republic
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, , Russian Federation
State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD", Kursk, , Russian Federation
Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre, Moscow, , Russian Federation
Pyatigorsk Oncology Dispensary, Pyatigorsk, , Russian Federation
Scientific-Research Institute of Oncology named after Petrov, Saint Petersburg, , Russian Federation
Saint-Petersburg State Medical University named after Pavlov, Saint Petersburg, , Russian Federation
State Healthcare Institution "Samara Regional Clinical Oncology Dispensary", Samara, , Russian Federation
Tula Regional Dispensary, Tula, , Russian Federation
Nottingham University Hospital, Nottingham, , United Kingdom
Contact Details
Name: Sr. Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
Name: United Kingdom Principal Investigator
Affiliation: Royal Bournemouth Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Poland Principal Investigator
Affiliation: Centrum Onkologii-Instytut im.
Role: PRINCIPAL_INVESTIGATOR
Name: Ireland Principal Investigator
Affiliation: St. Vincent's University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Germany Principal Investigator
Affiliation: Luisenkrankenhaus Duesseldorf
Role: PRINCIPAL_INVESTIGATOR
Name: Czech Republic Principal Investigator
Affiliation: Thomayer Faculty Hosptial L.G.
Role: PRINCIPAL_INVESTIGATOR
Name: Belgium Principal Investigator
Affiliation: Institut Jules Bordet - Medical Oncology and Translational Research
Role: PRINCIPAL_INVESTIGATOR
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