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Brief Title: The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Official Title: The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine
Study ID: NCT01492101
Brief Summary: The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens. The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Arizona Oncology Associates, PC - NAHOA, Flagstaff, Arizona, United States
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, Burbank, California, United States
University of Southern California, Los Angeles, California, United States
PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists, Oxnard, California, United States
Wilshire Oncology Medical Group, Inc., Pasadena, California, United States
Desert Hematology Oncology Medical Group, Rancho Mirage, California, United States
University of California San Francisco, San Francisco, California, United States
Stanford University School of Medicine, Stanford, California, United States
Kaiser Permanente, Vallejo, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Pre clinical Science Bldg LR3, Washington, District of Columbia, United States
Medstar, Washington, District of Columbia, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
University of Miami School of Medicine, Miami, Florida, United States
Advanced Medical Specialties, Miami, Florida, United States
Florida Cancer Research Institute, Plantation, Florida, United States
Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
Northeast Georgia Cancer Care, Athens, Georgia, United States
Peachtree Hematology Oncology Consultants, Atlanta, Georgia, United States
Emory University, Atlanta, Georgia, United States
Central Georgia Cancer Care, Macon, Georgia, United States
Northwest Georgia Oncology Centers, P.C., Marietta, Georgia, United States
Summit Cancer Care, P.C., Savannah, Georgia, United States
The University of Chicago Medicine, Chicago, Illinois, United States
Oncology Specialists, Niles, Illinois, United States
Illinois Cancer Care, P.C., Peoria, Illinois, United States
IU Health Simon Cancer Center, Indianapolis, Indiana, United States
Hall-Perrine Cancer Center, 3rd Floor, Cedar Rapids, Iowa, United States
Kansas City Cancer Center, Overland Park, Kansas, United States
Louisville Oncology Clinical Research Program, Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
Missouri Cancer Associates, Columbia, Missouri, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Frontier Cancer Center and Blood Institute, Billings, Montana, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hematology-Oncology Associates of Northern NJ, PA, Morristown, New Jersey, United States
The cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Cooper University Hospital, Voorhees, New Jersey, United States
UNM Cancer Center, Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Monte fiore, Bronx, New York, United States
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care, Bronx, New York, United States
Beth Israel Medical Center, New York, New York, United States
Cornell University, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Carolinas Hematology Oncology Associates, Charlotte, North Carolina, United States
DUMC, Duke South, Durham, North Carolina, United States
Sanford Research/USD, Fargo, North Dakota, United States
University of Cincinnati, Cincinnati, Ohio, United States
Comprehensive Breast Cancer, Columbus, Ohio, United States
Signal Point Clinical Research Center, Middletown, Ohio, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
Medical Oncology Associates of Wyoming Valley, PC, Kingston, Pennsylvania, United States
Cancer Centers of the Carolinas, Easley, South Carolina, United States
Sanford Research/USD, Sioux Falls, South Dakota, United States
The West Clinic, Memphis, Tennessee, United States
Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology-Abilene, Abilene, Texas, United States
Texas Oncology-Austin Midtown, Austin, Texas, United States
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center, Beaumont, Texas, United States
Texas Oncology-Bedford, Bedford, Texas, United States
Texas Oncology-Medical City Dallas, Dallas, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital, Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology-Denton South, Denton, Texas, United States
Texas Oncology-Fort Worth, Fort Worth, Texas, United States
Texas Oncology-Memorial City, Houston, Texas, United States
Texas Oncology-Lewisville, Lewisville, Texas, United States
Texas Oncology-Mesquite, Mesquite, Texas, United States
Texas Oncology-Midland Allison Cancer Center, Midland, Texas, United States
Texas Oncology, P.A. - Plano, Plano, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Texas Oncology - Sherman, Sherman, Texas, United States
Texas Oncology-Tyler, Tyler, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Salem, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Cancer Care Northwest, Spokane, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge, Yakima, Washington, United States
Cancer TEAM Bellin Health, Green Bay, Wisconsin, United States
Institut Jules Bordet, Bruxelles, , Belgium
GHdC - Site Notre Dame, Charleroi, , Belgium
Universtair Ziekenhuis Antwerpen, Edegem, , Belgium
UZ Gent Medische Oncologie, Gent, , Belgium
UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège- Site du Sart Tilman, Liège, , Belgium
Centre Hospitalier Universitaire Ambroise Paré, Mons,, , Belgium
GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY, Wilrijk, , Belgium
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Odette Cancer Centre OCC Clinical Research, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM-Hopital Notre-Dame, Montreal, Quebec, Canada
MUHC- Montreal General Hospital, Montreal, Quebec, Canada
Hôpital Charles-LeMoyne - CICM, Québec, , Canada
Institut Bergonie Service Oncologie Médicale, Bordeaux, , France
Sorecoh, Le Mans, , France
Centre Oscar Lambret, Lille Cedex, , France
Institut Paoli Calmettes, Service Pharmacie, Marseille, , France
Centra Regional de Lutte contre le Cancer, Montpellier, , France
Institut Curie, UGEC, Paris, , France
Hopital Tenon Service oncologie médicale, Paris, , France
Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau, Saint Herblain, , France
Institut de Cancérologie Gustave Roussy, Villejuif, , France
Klinikum St. Marien Amberg, Amberg, , Germany
Onkoplus, Berlin, , Germany
Oncoresearch, Dortmund, , Germany
Universitaetsklinikum Erlangen, Erlangen, , Germany
Wilhelm-Anton-Hospital gGmbH, Goch, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Ulm, Frauenklinik, Ulm, , Germany
Istituto tumori Giovanni Paolo II-ospedale oncologico, Oncologia Medica e Sperimentale, Bari, , Italy
Via Olgettina, Milano, , Italy
Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica, Pisa, , Italy
Oncologia Ospedale Infermi- Viale, Rimini, , Italy
Istituto Nazionale tumori Regina Elena IRCCS, Roma, , Italy
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Samsung Medical Center, Irwon-dong, Seoul, Korea, Republic of
Hematology-oncology Department, Ajou University Hospital, Sŏwŏn, Suwon, Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Hematology-oncology Department, Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital,, Soeul, , Korea, Republic of
VUmc, Amsterdam, , Netherlands
MUMC, Maastricht, , Netherlands
Tweesteden Ziekenhuis, Tilburg, , Netherlands
Leningrad Regional Oncology Dispensary, Kuz'molovskiy, , Russian Federation
State Institution "Russian Oncology Research Centre named after N.N. Blokhin RAMS", Moscow, , Russian Federation
Scientific Research Oncology Institute named after N.N. Petrov, Saint Petersburg, , Russian Federation
Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways", St. Petersburg, , Russian Federation
St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary", St. Petersburg, , Russian Federation
Hospital Vall d'Hebron, Barcelona, , Spain
ICO l´Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitari Arnau de Vilanova, Lleida, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
MD Anderson Cancer Center Arturo, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Sant Joan de Reus, Tarragona, , Spain
Clinical Trials Unit, Velindre Cancer Centre, Cardiff, , United Kingdom
Beaston Oncology Center, Glasgow, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
NCRN, London, , United Kingdom
The Christie Hospitals NHS Foundation Trust, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Cancer Clinical Trials Centre, Weston Park Hospital, Sheffield, , United Kingdom
Name: Alison Hannah, MD
Affiliation: Nektar Therapeutics
Role: STUDY_DIRECTOR