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Spots Global Cancer Trial Database for Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

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Trial Identification

Brief Title: Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

Official Title: A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Study ID: NCT01610284

Conditions

Breast Cancer

Study Description

Brief Summary: This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

Detailed Description: Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by PI3K pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on Response Evaluation Criteria In Solid Tumors \[RECIST\] version 1.1). Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2), Mobile, Alabama, United States

Arizona Oncology Associates Dept of Oncology, Phoenix, Arizona, United States

Highlands Oncology Group, Fayetteville, Arkansas, United States

Shapiro and Stafford and Yee and Polanski Study Coordinator, Arcadia, California, United States

Cancer Care Associates Dept.ofCancerCareAssoc., Fresno, California, United States

St. Jude Heritage Medical Group Virginia Crosson Cancer Center, Fullerton, California, United States

University of California San Diego - Moores Cancer Center UCSD 3, La Jolla, California, United States

Los Angeles Hematology/Oncology Medical Group LA Cancer Network, Los Angeles, California, United States

USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3), Los Angeles, California, United States

University of California at Los Angeles Dept. of UCLA, Los Angeles, California, United States

Ventura County Hematology and Oncology PMK Medical Group, Oxnard, California, United States

Coastal Integrative Cancer Care, San Luis Obispo, California, United States

Santa Barbara Hematolgy Oncology Medical Group, Santa Barbara, California, United States

Central Coast Medical Oncology Corporation, Santa Maria, California, United States

St Joseph Heritage Healthcare Dept. of RRMG (4), Santa Rosa, California, United States

Granada Hills Cancer Center, Valencia, California, United States

Kaiser Permanente Northwest Kaiser, Denver, Colorado, United States

Rocky Mountain Cancer Centers RMCC, Greenwood Village, Colorado, United States

Memorial Regional Cancer Center MRCC, Hollywood, Florida, United States

Cancer Specialists of North Florida SC - F2302, Jacksonville, Florida, United States

University of Miami Univ Miami 2, Miami, Florida, United States

MD Anderson Cancer Center - Orlando MD Orlando, Orlando, Florida, United States

Georgia Cancer Specialists SC, Decatur, Georgia, United States

North Shore University Health System, Evanston, Illinois, United States

Cadence Health, Geneva, Illinois, United States

Cancer Care and Hematology Specialists of Chicagoland Niles, Multiple Locations, Illinois, United States

Cancer Center of Kansas CCK, Wichita, Kansas, United States

Mercy Medical Center Mercy Medical SC, Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins, Baltimore, Maryland, United States

Frederick Memorial Hospital Fred. Mem. Hosp., Frederick, Maryland, United States

Maryland Oncology Hematology, P.A. SC, Rockville, Maryland, United States

Massachusetts General Hospital SC, Boston, Massachusetts, United States

West Michigan Cancer Center Dept of Oncology, Kalamazoo, Michigan, United States

Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint, Tupelo, Mississippi, United States

Washington University School of Medicine Regulatory, Saint Louis, Missouri, United States

Hackensack Meridian Health, Brick, New Jersey, United States

The Valley Hospital / Luckow Pavillion, Paramus, New Jersey, United States

Clinical Research Alliance SC-2, Lake Success, New York, United States

Memorial Sloan Kettering Dept Onc, New York, New York, United States

University of Rochester Medical Center Univ Rochester, Rochester, New York, United States

Levine Cancer Institute Levine Cancer Institute, Charlotte, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Case Western Reserve SC, Cleveland, Ohio, United States

Northwest Cancer Specialists Portland Loc, Portland, Oregon, United States

St. Luke's Hospital and Health Network St Luke's (2), Bethlehem, Pennsylvania, United States

Charleston Hematology Oncology Association PA, Charleston, South Carolina, United States

Tennessee Cancer Specialists, Knoxville, Tennessee, United States

Vanderbilt University Medical Center Vanderbilt - Thompson Ln, Nashville, Tennessee, United States

Texas Oncology P A Midtown, Dallas, Texas, United States

Texas Oncology P A TX Onc - Bedford, Dallas, Texas, United States

Texas Oncology P A TX Onc - Med City Dallas, Dallas, Texas, United States

Texas Oncology P A TX Onc - Southwest, Dallas, Texas, United States

Oncology Consultants Oncology Consultants, P.A., Houston, Texas, United States

Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development, San Antonio, Texas, United States

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City, Utah, United States

Oncology Hematology Associates of Southeast Virginia Salem VA Branch, Roanoke, Virginia, United States

Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc, Kennewick, Washington, United States

West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology, Morgantown, West Virginia, United States

Cancer TEAM Bellin Health Belin Health, Green Bay, Wisconsin, United States

Dean Health System Dean Hematology Oncology, Madison, Wisconsin, United States

University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3, Madison, Wisconsin, United States

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Novartis Investigative Site, Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site, San Miguel De Tucuman, Tucuman, Argentina

Novartis Investigative Site, Rio Negro, Viedma, Argentina

Novartis Investigative Site, Sydney, New South Wales, Australia

Novartis Investigative Site, Woollongong, New South Wales, Australia

Novartis Investigative Site, South Brisbane, Queensland, Australia

Novartis Investigative Site, Clayton, Victoria, Australia

Novartis Investigative Site, Melbourne, Victoria, Australia

Novartis Investigative Site, Murdoch, Western Australia, Australia

Novartis Investigative Site, Nedlands, Western Australia, Australia

Novartis Investigative Site, Linz, , Austria

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Wien, , Austria

Novartis Investigative Site, Jette, Brussel, Belgium

Novartis Investigative Site, Bruxelles, , Belgium

Novartis Investigative Site, Charleroi, , Belgium

Novartis Investigative Site, Leuven, , Belgium

Novartis Investigative Site, Liege, , Belgium

Novartis Investigative Site, Namur, , Belgium

Novartis Investigative Site, Wilrijk, , Belgium

Novartis Investigative Site, Belo Horizonte, MG, Brazil

Novartis Investigative Site, Curitiba, PR, Brazil

Novartis Investigative Site, Natal, RN, Brazil

Novartis Investigative Site, Ijuí, RS, Brazil

Novartis Investigative Site, Barretos, SP, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Sorocaba, SP, Brazil

Novartis Investigative Site, Calgary, Alberta, Canada

Novartis Investigative Site, Edmonton, Alberta, Canada

Novartis Investigative Site, Kelowna, British Columbia, Canada

Novartis Investigative Site, Vancouver, British Columbia, Canada

Novartis Investigative Site, Halifax, Nova Scotia, Canada

Novartis Investigative Site, Cambridge, Ontario, Canada

Novartis Investigative Site, London, Ontario, Canada

Novartis Investigative Site, Newmarket, Ontario, Canada

Novartis Investigative Site, Ottawa, Ontario, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Laval, Quebec, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Regina, Saskatchewan, Canada

Novartis Investigative Site, Quebec, , Canada

Novartis Investigative Site, Harbin, Heilongjiang, China

Novartis Investigative Site, Changsha, Hunan, China

Novartis Investigative Site, Nanjing, Jiangsu, China

Novartis Investigative Site, Shengyang, Liaoning, China

Novartis Investigative Site, Shanghai, Shanghai, China

Novartis Investigative Site, Chengdu, Sichuan, China

Novartis Investigative Site, Hangzhou, Zhejiang, China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Guangzhou, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Brno Bohunice, Czech Republic, Czechia

Novartis Investigative Site, Olomouc, CZE, Czechia

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Nice Cedex 2, Alpes Maritimes, France

Novartis Investigative Site, Dijon Cedex, Cote D Or, France

Novartis Investigative Site, Saint Priest en Jarez, Loire, France

Novartis Investigative Site, Angers Cedex 02, , France

Novartis Investigative Site, Avignon Cedex, , France

Novartis Investigative Site, Besancon cedex, , France

Novartis Investigative Site, Bordeaux, , France

Novartis Investigative Site, Caen Cedex, , France

Novartis Investigative Site, Clermont-Ferrand, , France

Novartis Investigative Site, Le Mans Cedex, , France

Novartis Investigative Site, Lille Cedex, , France

Novartis Investigative Site, Montpellier Cedex 5, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Rouen Cedex 1, , France

Novartis Investigative Site, Saint-Herblain Cédex, , France

Novartis Investigative Site, Strasbourg cedex, , France

Novartis Investigative Site, Toulouse Cedex 9, , France

Novartis Investigative Site, Villejuif Cedex, , France

Novartis Investigative Site, Langen, Hessen, Germany

Novartis Investigative Site, Recklinghausen, North Rhine-westphalia, Germany

Novartis Investigative Site, Luebeck, Schleswig-holstein, Germany

Novartis Investigative Site, Essen, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Hannover, , Germany

Novartis Investigative Site, Heidelberg, , Germany

Novartis Investigative Site, Kiel, , Germany

Novartis Investigative Site, Magdeburg, , Germany

Novartis Investigative Site, Mainz, , Germany

Novartis Investigative Site, Mannheim, , Germany

Novartis Investigative Site, Mühlhausen, , Germany

Novartis Investigative Site, München, , Germany

Novartis Investigative Site, Saarbruecken, , Germany

Novartis Investigative Site, Velbert, , Germany

Novartis Investigative Site, Wuerzburg, , Germany

Novartis Investigative Site, Thessaloniki, GR, Greece

Novartis Investigative Site, Athens, , Greece

Novartis Investigative Site, Heraklion Crete, , Greece

Novartis Investigative Site, Patras, , Greece

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Debrecen, , Hungary

Novartis Investigative Site, Miskolc, , Hungary

Novartis Investigative Site, Szolnok, , Hungary

Novartis Investigative Site, Haifa, , Israel

Novartis Investigative Site, Jerusalem, , Israel

Novartis Investigative Site, Petach Tikva, , Israel

Novartis Investigative Site, Ramat Gan, , Israel

Novartis Investigative Site, Tel Aviv, , Israel

Novartis Investigative Site, Cuneo, CN, Italy

Novartis Investigative Site, Cremona, CR, Italy

Novartis Investigative Site, Catanzaro, CZ, Italy

Novartis Investigative Site, Meldola, FC, Italy

Novartis Investigative Site, Firenze, FI, Italy

Novartis Investigative Site, Lido di Camaiore, LU, Italy

Novartis Investigative Site, Macerata, MC, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Rozzano, MI, Italy

Novartis Investigative Site, Pisa, PI, Italy

Novartis Investigative Site, Aviano, PN, Italy

Novartis Investigative Site, Roma, RM, Italy

Novartis Investigative Site, Roma, RM, Italy

Novartis Investigative Site, Roma, RM, Italy

Novartis Investigative Site, Rimini, RN, Italy

Novartis Investigative Site, Torino, TO, Italy

Novartis Investigative Site, Mirano, VE, Italy

Novartis Investigative Site, Bologna, , Italy

Novartis Investigative Site, Napoli, , Italy

Novartis Investigative Site, Nagoya, Aichi, Japan

Novartis Investigative Site, Kashiwa, Chiba, Japan

Novartis Investigative Site, Fukuoka-city, Fukuoka, Japan

Novartis Investigative Site, Maebashi city, Gunma, Japan

Novartis Investigative Site, Sapporo-city, Hokkaido, Japan

Novartis Investigative Site, Isehara, Kanagawa, Japan

Novartis Investigative Site, Yokohama-city, Kanagawa, Japan

Novartis Investigative Site, Kumamoto City, Kumamoto, Japan

Novartis Investigative Site, Sakyo Ku, Kyoto, Japan

Novartis Investigative Site, Osaka-city, Osaka, Japan

Novartis Investigative Site, Osaka-city, Osaka, Japan

Novartis Investigative Site, Suita city, Osaka, Japan

Novartis Investigative Site, Koto ku, Tokyo, Japan

Novartis Investigative Site, Suwon, Gyeonggi-do, Korea, Republic of

Novartis Investigative Site, Seoul, Seocho Gu, 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, Nijmegen, , Netherlands

Novartis Investigative Site, Surquillo, Lima, Peru

Novartis Investigative Site, Kraków, , Poland

Novartis Investigative Site, Olsztyn, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Nizhniy Novgorod, , Russian Federation

Novartis Investigative Site, St Petersburg, , Russian Federation

Novartis Investigative Site, St- Petersburg, , Russian Federation

Novartis Investigative Site, Singapore, , Singapore

Novartis Investigative Site, Bratislava, Slovak Republic, Slovakia

Novartis Investigative Site, Kosice, , Slovakia

Novartis Investigative Site, Johannesburg, , South Africa

Novartis Investigative Site, Parktown, , South Africa

Novartis Investigative Site, Elche, Alicante, Spain

Novartis Investigative Site, Cordoba, Andalucia, Spain

Novartis Investigative Site, Jaen, Andalucia, Spain

Novartis Investigative Site, Malaga, Andalucia, Spain

Novartis Investigative Site, Sevilla, Andalucia, Spain

Novartis Investigative Site, Sevilla, Andalucia, Spain

Novartis Investigative Site, Sevilla, Andalucia, Spain

Novartis Investigative Site, Oviedo, Asturias, Spain

Novartis Investigative Site, Toledo, Castilla La Mancha, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Barcelona, Cataluña, Spain

Novartis Investigative Site, Tarragona, Cataluña, 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, Las Palmas De Gran Canarias, Las Palmas De Gran Canaria, Spain

Novartis Investigative Site, San Sebastian de los Reyes, Madrid, Spain

Novartis Investigative Site, El Palmar, Murcia, 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, Zaragoza, , Spain

Novartis Investigative Site, Bellinzona, , Switzerland

Novartis Investigative Site, Genève, , Switzerland

Novartis Investigative Site, Zuerich, , Switzerland

Novartis Investigative Site, Kaohsiung, , Taiwan

Novartis Investigative Site, Kaohsiung, , Taiwan

Novartis Investigative Site, Taichung, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Truro, Cornwall, United Kingdom

Novartis Investigative Site, Bournemouth, , United Kingdom

Novartis Investigative Site, Derby, , United Kingdom

Novartis Investigative Site, Leicester, , United Kingdom

Novartis Investigative Site, Liverpool, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Manchester, , United Kingdom

Novartis Investigative Site, Oxford, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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