Spots Global Cancer Trial Database for Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
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Trial Identification
Brief Title: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
Official Title: A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Study ID: NCT02437318
Conditions
Study Description
Brief Summary: To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Centers Chandler 2, Chandler, Arizona, United States
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
City of Hope National Medical Center, Duarte, California, United States
Scripps Clinic SC, La Jolla, California, United States
Kaiser Permanente - California Southern, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Florida Cancer Specialists FL Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists-North SC, Saint Petersburg, Florida, United States
Rush University Medical Center Rush Uni Medical Center, Chicago, Illinois, United States
NorthShore University Health System NorthShore University, Evanston, Illinois, United States
Edward Cancer Center SC, Naperville, Illinois, United States
Fort Wayne Medical Oncology/Hematology, Inc. Dept.of Fort Wayne Med Onc/Hem, Fort Wayne, Indiana, United States
St. Francis Health Comprehensive Cancer Center SC, Topeka, Kansas, United States
Mercy Medical Center SC-2, Baltimore, Maryland, United States
Massachusetts General Hospital Updated Regulatory, Boston, Massachusetts, United States
Lahey Clinic, Burlington, Massachusetts, United States
Detroit Clinical Research Center, Owosso, Michigan, United States
St. Luke's Cancer Institute SC, Kansas City, Missouri, United States
St Vincent Frontier Cancer Center, Billings, Montana, United States
Rutgers Cancer Institute of New Jersey SC-2, New Brunswick, New Jersey, United States
University Hospitals of Cleveland Seidman Cancer Center SC, Cleveland, Ohio, United States
Good Samaritan Regional Medical Center Good Samaritan Reg Med Ctr, Corvallis, Oregon, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Prisma Health Upstate SC-2, Greenville, South Carolina, United States
Avera Cancer SC, Sioux Falls, South Dakota, United States
Tennessee Oncology SC-3, Nashville, Tennessee, United States
Texas Oncology PA Dallas Presbyterian Hospital SC-1, Dallas, Texas, United States
El Paso, Texas Oncology, El Paso, Texas, United States
Mays Cancer Ctr Uthsa Mdacc InstituteForDrugDevelopment(4), San Antonio, Texas, United States
Texas Oncology Northeast Texas, Tyler, Texas, United States
Virginia Cancer Specialists SC, Fairfax, Virginia, United States
Wenatchee Valley Medical Center SC-2, Wenatchee, Washington, United States
Novartis Investigative Site, Berazategui, Buenos Aires, Argentina
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, Rio Negro, Viedma, Argentina
Novartis Investigative Site, La Rioja, , Argentina
Novartis Investigative Site, Wahroonga, New South Wales, Australia
Novartis Investigative Site, Wooloongabba, Queensland, Australia
Novartis Investigative Site, Elizabeth Vale, South Australia, Australia
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Linz, , Austria
Novartis Investigative Site, Vienna, , Austria
Novartis Investigative Site, Edegem, Antwerpen, Belgium
Novartis Investigative Site, Jette, Brussel, Belgium
Novartis Investigative Site, Sint Niklaas, Oost Vlaanderen, Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Libramont, , Belgium
Novartis Investigative Site, Ottignies, , Belgium
Novartis Investigative Site, Verviers, , Belgium
Novartis Investigative Site, Natal, RN, Brazil
Novartis Investigative Site, Lajeado, RS, Brazil
Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Sao Jose do Rio Preto, , Brazil
Novartis Investigative Site, Sao Paulo, , Brazil
Novartis Investigative Site, Plovdiv, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, Varna, , Bulgaria
Novartis Investigative Site, Varna, , Bulgaria
Novartis Investigative Site, Calgary, Alberta, Canada
Novartis Investigative Site, Cambridge, Ontario, Canada
Novartis Investigative Site, Ottawa, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Quebec, , Canada
Novartis Investigative Site, Temuco, Araucania, Chile
Novartis Investigative Site, Santiago, , Chile
Novartis Investigative Site, Vina del Mar, , Chile
Novartis Investigative Site, Hradec Kralove, Czech Republic, Czechia
Novartis Investigative Site, Praha 4, Czech Republic, Czechia
Novartis Investigative Site, Zlin, Czech Republic, Czechia
Novartis Investigative Site, Prague 8, , Czechia
Novartis Investigative Site, Marseille cedex 20, Bouches Du Rhone, France
Novartis Investigative Site, Angers 02, , France
Novartis Investigative Site, Avignon, , France
Novartis Investigative Site, Caen, , France
Novartis Investigative Site, Clermont Ferrand, , France
Novartis Investigative Site, Creteil, , France
Novartis Investigative Site, La Roche sur Yon cedex 9, , France
Novartis Investigative Site, Le Chesnay, , France
Novartis Investigative Site, Levallois-Perret, , France
Novartis Investigative Site, Lyon Cedex 08, , France
Novartis Investigative Site, Montpellier, , France
Novartis Investigative Site, Nimes, , France
Novartis Investigative Site, Rouen, , France
Novartis Investigative Site, Saint-Herblain Cédex, , France
Novartis Investigative Site, Toulouse, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Recklinghausen, North Rhine-westphalia, Germany
Novartis Investigative Site, Leipzig, Sachsen, Germany
Novartis Investigative Site, Luebeck, Schleswig-Holstein, Germany
Novartis Investigative Site, Aschaffenburg, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Friedrichshafen, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Homburg, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Potsdam, , Germany
Novartis Investigative Site, Rostock, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Velbert, , Germany
Novartis Investigative Site, Thessaloniki, GR, Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Nyiregyhaza, , Hungary
Novartis Investigative Site, Szekszard, , Hungary
Novartis Investigative Site, Vijayawada, Andhra Pradesh, India
Novartis Investigative Site, Nagpur - Maharashtra, Maharashtra, India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, Beer-Sheva, , Israel
Novartis Investigative Site, Haifa, , Israel
Novartis Investigative Site, Petach Tikva, , Israel
Novartis Investigative Site, Ramat Gan, , Israel
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Ancona, AN, Italy
Novartis Investigative Site, Chieti, CH, Italy
Novartis Investigative Site, Meldola, FC, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Palermo, PA, Italy
Novartis Investigative Site, Padova, PD, Italy
Novartis Investigative Site, Pontedera, PI, Italy
Novartis Investigative Site, Aviano, PN, Italy
Novartis Investigative Site, Rionero in Vulture, PZ, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Sassari, SS, Italy
Novartis Investigative Site, Savona, SV, Italy
Novartis Investigative Site, Torino, TO, Italy
Novartis Investigative Site, Negrar, VR, Italy
Novartis Investigative Site, Nagoya, Aichi, Japan
Novartis Investigative Site, Matsuyama, Ehime, Japan
Novartis Investigative Site, Maebashi city, Gunma, Japan
Novartis Investigative Site, Sapporo-city, Hokkaido, Japan
Novartis Investigative Site, Akashi, Hyogo, Japan
Novartis Investigative Site, Kagoshima-city, Kagoshima, Japan
Novartis Investigative Site, Isehara, Kanagawa, Japan
Novartis Investigative Site, Yokohama-city, Kanagawa, Japan
Novartis Investigative Site, Kumamoto City, Kumamoto, Japan
Novartis Investigative Site, Osaka-city, Osaka, Japan
Novartis Investigative Site, Osaka-city, Osaka, Japan
Novartis Investigative Site, Kitaadachi-gun, Saitama, Japan
Novartis Investigative Site, Chuo ku, Tokyo, Japan
Novartis Investigative Site, Minato ku, Tokyo, Japan
Novartis Investigative Site, Bundang Gu, Gyeonggi Do, Korea, Republic of
Novartis Investigative Site, Gyeonggi do, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Ashrafieh, , Lebanon
Novartis Investigative Site, Beirut, , Lebanon
Novartis Investigative Site, Saida, , Lebanon
Novartis Investigative Site, Monterrey NL, Monterrey, Mexico
Novartis Investigative Site, San Luis Potosi, , Mexico
Novartis Investigative Site, Venray, CE, Netherlands
Novartis Investigative Site, Terneuzen, , Netherlands
Novartis Investigative Site, San Borja, Lima, Peru
Novartis Investigative Site, Surquillo, Lima, Peru
Novartis Investigative Site, Lima, , Peru
Novartis Investigative Site, Floresti, Cluj, Romania
Novartis Investigative Site, Craiova, Dolj, Romania
Novartis Investigative Site, Iasi, , Romania
Novartis Investigative Site, Arkhangelsk, , Russian Federation
Novartis Investigative Site, Ryazan, , Russian Federation
Novartis Investigative Site, St Petersburg, , Russian Federation
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Jerez, Cadiz, Spain
Novartis Investigative Site, Barcelona, Cataluna, Spain
Novartis Investigative Site, Badalona, Catalunya, Spain
Novartis Investigative Site, Alicante, Comunidad Valenciana, Spain
Novartis Investigative Site, Castellon, Comunidad Valenciana, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Badajoz, Extremadura, Spain
Novartis Investigative Site, Caceres, Extremadura, Spain
Novartis Investigative Site, Santiago de Compostela, Galicia, Spain
Novartis Investigative Site, Palma De Mallorca, Islas Baleares, Spain
Novartis Investigative Site, Pozuelo de Alarcon, Madrid, Spain
Novartis Investigative Site, El Palmar, Murcia, Spain
Novartis Investigative Site, La Laguna, Santa Cruz De Tenerife, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Gavle, , Sweden
Novartis Investigative Site, Oerebro, , Sweden
Novartis Investigative Site, Vasteras, , Sweden
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Bangkok, THA, Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Plymouth, Devon, United Kingdom
Novartis Investigative Site, Leicester, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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