Breast Cancer Clinical Trial
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
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.
Full 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 Criteria
Key Inclusion Criteria:
Locally advanced or metastatic breast cancer
HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
Postmenopausal woman
A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
Adequate bone marrow and organ function defined by laboratory values
Key Exclusion Criteria:
Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
More than one prior chemotherapy line for metastatic disease
Symptomatic brain metastases
Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Active heart (cardiac) disease as defined in the protocol
Certain scores on an anxiety and depression mood questionnaires
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There are 257 Locations for this study
Mobile Alabama, 36688, United States
Phoenix Arizona, , United States
Fayetteville Arkansas, 72703, United States
Arcadia California, 91007, United States
Fresno California, 93720, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Los Angeles California, 90017, United States
Los Angeles California, 90053, United States
Los Angeles California, 90095, United States
Oxnard California, 93030, United States
San Luis Obispo California, 93401, United States
Santa Barbara California, 93105, United States
Santa Maria California, 93454, United States
Santa Rosa California, 94503, United States
Valencia California, 91355, United States
Denver Colorado, , United States
Greenwood Village Colorado, , United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32258, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Decatur Georgia, 30033, United States
Evanston Illinois, 60201, United States
Geneva Illinois, 60134, United States
Multiple Locations Illinois, , United States
Wichita Kansas, 67214, United States
Baltimore Maryland, 21202, United States
Baltimore Maryland, 21231, United States
Frederick Maryland, 21701, United States
Rockville Maryland, 20850, United States
Boston Massachusetts, 02114, United States
Kalamazoo Michigan, 49007, United States
Tupelo Mississippi, 38801, United States
Saint Louis Missouri, 63110, United States
Brick New Jersey, 08724, United States
Paramus New Jersey, 07652, United States
Lake Success New York, 11042, United States
New York New York, 10017, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28203, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97210, United States
Bethlehem Pennsylvania, 18015, United States
Charleston South Carolina, 29414, United States
Knoxville Tennessee, 37909, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75251, United States
Dallas Texas, 75251, United States
Dallas Texas, 75251, United States
Dallas Texas, 75251, United States
Houston Texas, 77024, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84106, United States
Roanoke Virginia, 24014, United States
Kennewick Washington, 99336, United States
Morgantown West Virginia, 26506, United States
Green Bay Wisconsin, 54313, United States
Madison Wisconsin, 53717, United States
Madison Wisconsin, 53792, United States
Caba Buenos Aires, C1050, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
San Miguel De Tucuman Tucuman, T4000, Argentina
Rio Negro Viedma, 8500, Argentina
Sydney New South Wales, 2060, Australia
Woollongong New South Wales, 2500, Australia
South Brisbane Queensland, 4101, Australia
Clayton Victoria, 3168, Australia
Melbourne Victoria, 3000, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Linz , 4010, Austria
Salzburg , 5020, Austria
Wien , A-109, Austria
Jette Brussel, 1090, Belgium
Bruxelles , 1000, Belgium
Charleroi , 6000, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Belo Horizonte MG, 30150, Brazil
Curitiba PR, 81520, Brazil
Natal RN, 59075, Brazil
Ijuà RS, 98700, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Sorocaba SP, , Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 1, Canada
Cambridge Ontario, N1R 3, Canada
London Ontario, N6A 4, Canada
Newmarket Ontario, J7Y 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H2L 4, Canada
Regina Saskatchewan, S4T 7, Canada
Quebec , G1S 4, Canada
Harbin Heilongjiang, 15008, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Shengyang Liaoning, 11004, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Hangzhou Zhejiang, 31002, China
Beijing , 10003, China
Guangzhou , 51006, China
Shanghai , 20002, China
Brno Bohunice Czech Republic, 625 0, Czechia
Olomouc CZE, 775 2, Czechia
Brno , 65653, Czechia
Nice Cedex 2 Alpes Maritimes, 06189, France
Dijon Cedex Cote D Or, 21034, France
Saint Priest en Jarez Loire, 42270, France
Angers Cedex 02 , 49055, France
Avignon Cedex , 84082, France
Besancon cedex , 25030, France
Bordeaux , 33076, France
Caen Cedex , 14021, France
Clermont-Ferrand , 63011, France
Le Mans Cedex , 72015, France
Lille Cedex , 59020, France
Montpellier Cedex 5 , 34298, France
Paris , 75010, France
Paris , 75231, France
Rouen Cedex 1 , 76038, France
Saint-Herblain Cédex , 44805, France
Strasbourg cedex , 67085, France
Toulouse Cedex 9 , 31059, France
Villejuif Cedex , 94800, France
Langen Hessen, 63225, Germany
Recklinghausen North Rhine-westphalia, 45657, Germany
Luebeck Schleswig-holstein, 23563, Germany
Essen , 45147, Germany
Hamburg , 20249, Germany
Hannover , 30177, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Magdeburg , 39108, Germany
Mainz , 55131, Germany
Mannheim , 68165, Germany
Mühlhausen , 99974, Germany
München , 80638, Germany
Saarbruecken , 66113, Germany
Velbert , 42551, Germany
Wuerzburg , 97080, Germany
Thessaloniki GR, 54645, Greece
Athens , 115 2, Greece
Heraklion Crete , 711 1, Greece
Patras , 265 0, Greece
Budapest , H 112, Hungary
Debrecen , 4032, Hungary
Miskolc , 3526, Hungary
Szolnok , H-500, Hungary
Haifa , 35254, Israel
Jerusalem , 91120, Israel
Petach Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Cuneo CN, 12100, Italy
Cremona CR, 26100, Italy
Catanzaro CZ, 88100, Italy
Meldola FC, 47014, Italy
Firenze FI, 50134, Italy
Lido di Camaiore LU, 55041, Italy
Macerata MC, 62100, Italy
Milano MI, 20122, Italy
Milano MI, 20133, Italy
Milano MI, 20141, Italy
Milano MI, 20162, Italy
Rozzano MI, 20089, Italy
Pisa PI, 56126, Italy
Aviano PN, 33081, Italy
Roma RM, 00128, Italy
Roma RM, 00161, Italy
Roma RM, 00189, Italy
Rimini RN, 47900, Italy
Torino TO, 10126, Italy
Mirano VE, 30035, Italy
Bologna , 40138, Italy
Napoli , 80131, Italy
Nagoya Aichi, 464 8, Japan
Kashiwa Chiba, 277 8, Japan
Fukuoka-city Fukuoka, 811-1, Japan
Maebashi city Gunma, 371 8, Japan
Sapporo-city Hokkaido, 003-0, Japan
Isehara Kanagawa, 259-1, Japan
Yokohama-city Kanagawa, 241-8, Japan
Kumamoto City Kumamoto, 860-8, Japan
Sakyo Ku Kyoto, 606 8, Japan
Osaka-city Osaka, 540-0, Japan
Osaka-city Osaka, 541-8, Japan
Suita city Osaka, 565 0, Japan
Koto ku Tokyo, 135 8, Japan
Suwon Gyeonggi-do, 44338, Korea, Republic of
Seoul Seocho Gu, 06591, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Nijmegen , 6500 , Netherlands
Surquillo Lima, 34, Peru
Kraków , , Poland
Olsztyn , 10-51, Poland
Warszawa , 02-77, Poland
Moscow , 11547, Russian Federation
Moscow , 11599, Russian Federation
Nizhniy Novgorod , 60308, Russian Federation
St Petersburg , 19775, Russian Federation
St- Petersburg , 19702, Russian Federation
Singapore , 16961, Singapore
Bratislava Slovak Republic, 83310, Slovakia
Kosice , 041 9, Slovakia
Johannesburg , 2196, South Africa
Parktown , 2193, South Africa
Elche Alicante, 03203, Spain
Cordoba Andalucia, 14004, Spain
Jaen Andalucia, 23007, Spain
Malaga Andalucia, 29010, Spain
Sevilla Andalucia, 41009, Spain
Sevilla Andalucia, 41013, Spain
Sevilla Andalucia, 41014, Spain
Oviedo Asturias, 33006, Spain
Toledo Castilla La Mancha, 45071, Spain
Barcelona Catalunya, 08003, Spain
Barcelona Catalunya, 08035, Spain
Barcelona Catalunya, 08036, Spain
Barcelona Cataluña, 08024, Spain
Tarragona Cataluña, 43007, Spain
Valencia Comunidad Valenciana, 46009, Spain
Valencia Comunidad Valenciana, 46010, Spain
Valencia Comunidad Valenciana, 46026, Spain
Las Palmas De Gran Canarias Las Palmas De Gran Canaria, 35016, Spain
San Sebastian de los Reyes Madrid, 28702, Spain
El Palmar Murcia, 30120, Spain
Barcelona , 08041, Spain
Madrid , 28009, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Madrid , 28222, Spain
Zaragoza , 50009, Spain
Bellinzona , 6500, Switzerland
Genève , 1211, Switzerland
Zuerich , 8038, Switzerland
Kaohsiung , 80756, Taiwan
Kaohsiung , 833, Taiwan
Taichung , 40447, Taiwan
Taipei , 10048, Taiwan
Taipei , 112, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Truro Cornwall, TR1 3, United Kingdom
Bournemouth , BH7 7, United Kingdom
Derby , DE22 , United Kingdom
Leicester , LE1 5, United Kingdom
Liverpool , L7 8X, United Kingdom
London , SE1 9, United Kingdom
London , WC1E , United Kingdom
Manchester , M20 2, United Kingdom
Oxford , OX3 7, United Kingdom
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