Spots Global Cancer Trial Database for A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
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Trial Identification
Brief Title: A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
Official Title: A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment
Study ID: NCT01633060
Conditions
Study Description
Brief Summary: This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).
Detailed Description: Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016, Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study was terminated.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of South Alabama / Mitchell Cancer Institute Univ South AL, Mobile, Alabama, United States
Ironwood Cancer and Research Centers SC, Chandler, Arizona, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Compassionate Cancer Care Medical Group CCCMG, Fountain Valley, California, United States
Los Angeles Hematology/Oncology Medical Group Onc Dept., Los Angeles, California, United States
Cedars Sinai Medical Center SC-5, Los Angeles, California, United States
University of California at Los Angeles UCLA SC, Los Angeles, California, United States
Pacific Cancer Care, Monterey, California, United States
Rocky Mountain Cancer Centers SC, Denver, Colorado, United States
University Cancer & Blood Center, LLC, Athens, Georgia, United States
Emory University School of Medicine/Winship Cancer Institute Emory, Atlanta, Georgia, United States
Moanalua Medical Center. Attn: Oncology Dept, Honolulu, Hawaii, United States
Edward Hospital Edward Hospital, Naperville, Illinois, United States
Crescent City Research Consortium, LLC SC, Metairie, Louisiana, United States
Lsu Health Sciences Center/ Lsu School of Medicine Lsu, New Orleans, Louisiana, United States
John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2, New Orleans, Louisiana, United States
LSU Health Sciences Center Feist-Weiller Cancer Center, New Orleans, Louisiana, United States
University of Maryland Medical Center Univ Maryland, Baltimore, Maryland, United States
Mercy Medical Research Institute SC, Manchester, Missouri, United States
Morristown Memorial Hospital Morristown Mem, Morristown, New Jersey, United States
CINJ at Cooper University Hospital Dept of Onc, Voorhees, New Jersey, United States
Montefiore Medical Center Montefiore, Bronx, New York, United States
Clinical Research Alliance BKM120F2303, Lake Success, New York, United States
Clinical Research Alliance, Lake Success, New York, United States
Northwest Cancer Specialists Compass Oncology -BKM, Portland, Oregon, United States
Oregon Health and Science University SC-5, Portland, Oregon, United States
University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital, Pittsburgh, Pennsylvania, United States
The West Clinic Dept. of the West Clinic, Memphis, Tennessee, United States
Texas Oncology PA Dallas Presbyterian Hospital SC, Dallas, Texas, United States
Texas Oncology Texas Oncology - Sammons, Dallas, Texas, United States
Texas Oncology P A SC-Austin, Dallas, Texas, United States
Texas Oncology P A Texas Oncology - Fort Worth (3, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Tech University Health Science Center Dept of Texas Tech, El Paso, Texas, United States
The Methodist Hospital Cancer Center, Houston, Texas, United States
US Oncology, P.A., Tyler, Texas, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, Rosario, Santa Fe, Argentina
Novartis Investigative Site, San Miguel De Tucuman, Tucuman, Argentina
Novartis Investigative Site, Rio Negro, Viedma, Argentina
Novartis Investigative Site, Innsbruck, Tyrol, Austria
Novartis Investigative Site, Linz, , Austria
Novartis Investigative Site, Salzburg, , Austria
Novartis Investigative Site, Wien, , Austria
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Liege, , Belgium
Novartis Investigative Site, Namur, , Belgium
Novartis Investigative Site, Plovdiv, , Bulgaria
Novartis Investigative Site, Plovdiv, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, Varna, , Bulgaria
Novartis Investigative Site, Vratsa, , Bulgaria
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Bogota, , Colombia
Novartis Investigative Site, Monteria, , Colombia
Novartis Investigative Site, Tampere, , Finland
Novartis Investigative Site, Nice Cedex 2, Alpes Maritimes, France
Novartis Investigative Site, Limoges cedex, Haute Vienne, France
Novartis Investigative Site, Saint-Cloud, Hauts De Seine, France
Novartis Investigative Site, Reims Cedex, Marne, France
Novartis Investigative Site, Angers Cedex 02, , France
Novartis Investigative Site, Clermont-Ferrand, , France
Novartis Investigative Site, Lyon Cedex, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Rouen Cedex 1, , France
Novartis Investigative Site, Saint-Brieuc Cédex, , France
Novartis Investigative Site, Saint-Herblain Cédex, , France
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bonn, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Erlangen, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Fulda, , Germany
Novartis Investigative Site, Karlsruhe, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Leer, , Germany
Novartis Investigative Site, Magdeburg, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Mühlhausen, , Germany
Novartis Investigative Site, Ravensburg, , Germany
Novartis Investigative Site, Soest, , Germany
Novartis Investigative Site, Tuebingen, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Velbert, , Germany
Novartis Investigative Site, Marousi, Athens, Greece
Novartis Investigative Site, Athens, GR, Greece
Novartis Investigative Site, Larissa, GR, Greece
Novartis Investigative Site, Patra - RIO, GR, Greece
Novartis Investigative Site, Thesaloniki, Thessaloniki, Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Heraklion Crete, , Greece
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Szeged, , Hungary
Novartis Investigative Site, Szolnok, , Hungary
Novartis Investigative Site, L'Aquila, AQ, Italy
Novartis Investigative Site, Bari, BA, Italy
Novartis Investigative Site, Benevento, BN, Italy
Novartis Investigative Site, Brindisi, BR, Italy
Novartis Investigative Site, Brescia, BS, Italy
Novartis Investigative Site, Monserrato, CA, Italy
Novartis Investigative Site, Cremona, CR, Italy
Novartis Investigative Site, Catania, CT, Italy
Novartis Investigative Site, Meldola, FC, Italy
Novartis Investigative Site, Cona, FE, Italy
Novartis Investigative Site, Firenze, FI, Italy
Novartis Investigative Site, Sora, FR, Italy
Novartis Investigative Site, Lecco, LC, Italy
Novartis Investigative Site, Lecce, LE, Italy
Novartis Investigative Site, Monza, MB, Italy
Novartis Investigative Site, Macerata, MC, Italy
Novartis Investigative Site, Messina, ME, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Modena, MO, Italy
Novartis Investigative Site, Padova, PD, Italy
Novartis Investigative Site, Pisa, PI, Italy
Novartis Investigative Site, Pordenone, PN, Italy
Novartis Investigative Site, Prato, PO, Italy
Novartis Investigative Site, Parma, PR, Italy
Novartis Investigative Site, Pavia, PV, Italy
Novartis Investigative Site, Reggio Calabria, RC, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Salerno, SA, Italy
Novartis Investigative Site, Sassari, SS, Italy
Novartis Investigative Site, Candiolo, TO, Italy
Novartis Investigative Site, Ivrea, TO, Italy
Novartis Investigative Site, Torino, TO, Italy
Novartis Investigative Site, Mirano, VE, Italy
Novartis Investigative Site, Verona, VR, Italy
Novartis Investigative Site, Frattamaggiore, , Italy
Novartis Investigative Site, Gyeonggi-do, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, 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, Maastricht, AZ, Netherlands
Novartis Investigative Site, Breda, , Netherlands
Novartis Investigative Site, Delft, , Netherlands
Novartis Investigative Site, Deventer, , Netherlands
Novartis Investigative Site, Hoofddorp, , Netherlands
Novartis Investigative Site, Leiden, , Netherlands
Novartis Investigative Site, Sittard-Geleen, , Netherlands
Novartis Investigative Site, Zwolle, , Netherlands
Novartis Investigative Site, Bergen, , Norway
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Olsztyn, , Poland
Novartis Investigative Site, Elche, Alicante, Spain
Novartis Investigative Site, Jaen, Andalucia, Spain
Novartis Investigative Site, Malaga, Andalucia, Spain
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Badalona, Catalunya, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Castellon, Comunidad Valenciana, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, La Coruna, Galicia, Spain
Novartis Investigative Site, Santiago de Compostela, Galicia, Spain
Novartis Investigative Site, Palma De Mallorca, Islas Baleares, Spain
Novartis Investigative Site, La Laguna, Santa Cruz De Tenerife, Spain
Novartis Investigative Site, Barcelona, , 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, Madrid, , Spain
Novartis Investigative Site, Santa Cruz de Tenerife, , Spain
Novartis Investigative Site, Kalmar, , Sweden
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Uppsala, , Sweden
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Blackburn, Lancashire, United Kingdom
Novartis Investigative Site, Ipswich, Suffolk, United Kingdom
Novartis Investigative Site, Edinburgh, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Novartis Investigative Site, Nottingham, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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