Spots Global Cancer Trial Database for A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
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Trial Identification
Brief Title: A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Official Title: A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Study ID: NCT01905592
Study Description
Brief Summary: The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
Detailed Description: This is a phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician's choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients. Niraparib is an orally active PARP inhibitor. Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of life will be measured. The safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, Tucson, Arizona, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Fort Myers, Florida, United States
GSK Investigational Site, Miami, Florida, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Omaha, Nebraska, United States
GSK Investigational Site, Henderson, Nevada, United States
GSK Investigational Site, Clifton Park, New York, United States
GSK Investigational Site, Lake Success, New York, United States
GSK Investigational Site, Cleveland, Ohio, United States
GSK Investigational Site, Eugene, Oregon, United States
GSK Investigational Site, Portland, Oregon, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Nashville, Tennessee, United States
GSK Investigational Site, Nashville, Tennessee, United States
GSK Investigational Site, Dallas, Texas, United States
GSK Investigational Site, Fort Worth, Texas, United States
GSK Investigational Site, San Antonio, Texas, United States
GSK Investigational Site, Webster, Texas, United States
GSK Investigational Site, Weslaco, Texas, United States
GSK Investigational Site, Low Moor, Virginia, United States
GSK Investigational Site, Everett, Washington, United States
GSK Investigational Site, Seattle, Washington, United States
GSK Investigational Site, Green Bay, Wisconsin, United States
GSK Investigational Site, Aalst, , Belgium
GSK Investigational Site, Brussels, , Belgium
GSK Investigational Site, Bruxelles, , Belgium
GSK Investigational Site, Edegem, , Belgium
GSK Investigational Site, Liège, , Belgium
GSK Investigational Site, Namur, , Belgium
GSK Investigational Site, Calgary, Alberta, Canada
GSK Investigational Site, Kelowna, British Columbia, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Bordeaux, , France
GSK Investigational Site, Dijon Cedex, , France
GSK Investigational Site, Lille Cedex, , France
GSK Investigational Site, Lyon Cedex 08, , France
GSK Investigational Site, Montpellier, , France
GSK Investigational Site, Nantes cedex, , France
GSK Investigational Site, Paris Cedex 5, , France
GSK Investigational Site, Saint-Cloud, , France
GSK Investigational Site, Heraklion,Crete, , Greece
GSK Investigational Site, Maroussi, , Greece
GSK Investigational Site, Nea Kifissia, , Greece
GSK Investigational Site, Neo Faliro, , Greece
GSK Investigational Site, Thessaloniki, , Greece
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Debrecen, , Hungary
GSK Investigational Site, Miskolc, , Hungary
GSK Investigational Site, Nyiregyhaza, , Hungary
GSK Investigational Site, Pécs, , Hungary
GSK Investigational Site, Szeged, , Hungary
GSK Investigational Site, Reykjavik, , Iceland
GSK Investigational Site, Haifa, , Israel
GSK Investigational Site, Holon, , Israel
GSK Investigational Site, Kfar-Saba, , Israel
GSK Investigational Site, Rehovot, , Israel
GSK Investigational Site, Tel Aviv, , Israel
GSK Investigational Site, Tel Hashomer, , Israel
GSK Investigational Site, Meldola (FC), Emilia-Romagna, Italy
GSK Investigational Site, Parma, Emilia-Romagna, Italy
GSK Investigational Site, Rimini, Emilia-Romagna, Italy
GSK Investigational Site, Viterbo, Lazio, Italy
GSK Investigational Site, Genova, Liguria, Italy
GSK Investigational Site, Cremona, Lombardia, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Ancona, Marche, Italy
GSK Investigational Site, Lecce, Puglia, Italy
GSK Investigational Site, Prato, Toscana, Italy
GSK Investigational Site, Legnago (VR), Veneto, Italy
GSK Investigational Site, Leiden, RC, , Netherlands
GSK Investigational Site, Limburg, , Netherlands
GSK Investigational Site, Zwolle, , Netherlands
GSK Investigational Site, Lodz, , Poland
GSK Investigational Site, Raciborz, , Poland
GSK Investigational Site, Coimbra, , Portugal
GSK Investigational Site, Lisbon, , Portugal
GSK Investigational Site, Porto, , Portugal
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Burgos, , Spain
GSK Investigational Site, Cáceres, , Spain
GSK Investigational Site, L'Hospitalet de Llobregat, , Spain
GSK Investigational Site, Lerida, , Spain
GSK Investigational Site, Lugo, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Pamplona, , Spain
GSK Investigational Site, Valencia, , Spain
GSK Investigational Site, Valencia, , Spain
GSK Investigational Site, Vigo, , Spain
GSK Investigational Site, Southampton, Hampshire, United Kingdom
GSK Investigational Site, Northwood, Middlesex, United Kingdom
GSK Investigational Site, Headington, Oxford, Oxfordshire, United Kingdom
GSK Investigational Site, Sutton, Surrey, United Kingdom
GSK Investigational Site, Bebington, Wirral, , United Kingdom
GSK Investigational Site, Belfast, , United Kingdom
GSK Investigational Site, Edinburgh, , United Kingdom
GSK Investigational Site, Glasgow, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Nottingham, , United Kingdom
GSK Investigational Site, Whitchurch, Cardiff, , United Kingdom
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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