Clinical trial NCT01610284: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
Hormone receptor positive
HER2-negative
Metastatic
Locally advanced
PI3K
Fulvestrant
Refractory
Aromatase inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 1147
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
timeFrame: Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to approximately 4 years
Secondary outcomes:
measure: Overall Survival (OS) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
timeFrame: Every 3 months following end of treatment visit, assessed for approximately 5 years
measure: Overall Response Rate (ORR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
timeFrame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 5 years
measure: Clinical Benefit Rate (CBR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
timeFrame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 5 years
measure: Number of Participants With On-Treatments Adverse Events, Serious Adverse Events and Deaths
timeFrame: From first dose of study treatment to 30 days after last dose of study treatment, assessed for approximately 5 years
measure: Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 2 Day 1
timeFrame: Cycle2 Day1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose). Each cycle is 28 days.
measure: Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)
timeFrame: Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1. Each cycle is 28 days.
measure: Median Time to Definitive Deterioration of the ECOG Performance Status - Full Analysis Set (FAS)
timeFrame: Up to approx 27 months
measure: Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30
timeFrame: Cycle 1 day 1, cycle 1 day 15, 6 weeks after randomisation and then every 8 weeks until end of treatment
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)
state: Alabama
city: Phoenix
country: United States
facility: Arizona Oncology Associates Dept of Oncology
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Arcadia
country: United States
facility: Shapiro and Stafford and Yee and Polanski Study Coordinator
state: California
city: Fresno
country: United States
facility: Cancer Care Associates Dept.ofCancerCareAssoc.
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego - Moores Cancer Center UCSD 3
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology/Oncology Medical Group LA Cancer Network
state: California
city: Los Angeles
country: United States
facility: USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles Dept. of UCLA
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology and Oncology PMK Medical Group
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematolgy Oncology Medical Group
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare Dept. of RRMG (4)
state: California
city: Valencia
country: United States
facility: Granada Hills Cancer Center
state: California
city: Denver
country: United States
facility: Kaiser Permanente Northwest Kaiser
state: Colorado
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers RMCC
state: Colorado
city: Hollywood
country: United States
facility: Memorial Regional Cancer Center MRCC
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida SC - F2302
state: Florida
city: Miami
country: United States
facility: University of Miami Univ Miami 2
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center - Orlando MD Orlando
state: Florida
city: Decatur
country: United States
facility: Georgia Cancer Specialists SC
state: Georgia
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Geneva
country: United States
facility: Cadence Health
state: Illinois
city: Multiple Locations
country: United States
facility: Cancer Care and Hematology Specialists of Chicagoland Niles
state: Illinois
city: Wichita
country: United States
facility: Cancer Center of Kansas CCK
state: Kansas
city: Baltimore
country: United States
facility: Mercy Medical Center Mercy Medical SC
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital Fred. Mem. Hosp.
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology, P.A. SC
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital SC
state: Massachusetts
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center Dept of Oncology
state: Michigan
city: Tupelo
country: United States
facility: Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine Regulatory
state: Missouri
city: Brick
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital / Luckow Pavillion
state: New Jersey
city: Lake Success
country: United States
facility: Clinical Research Alliance SC-2
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Dept Onc
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center Univ Rochester
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve SC
state: Ohio
city: Portland
country: United States
facility: Northwest Cancer Specialists Portland Loc
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital and Health Network St Luke's (2)
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Association PA
state: South Carolina
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Vanderbilt - Thompson Ln
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology P A Midtown
state: Texas
city: Dallas
country: United States
facility: Texas Oncology P A TX Onc - Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology P A TX Onc - Med City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology P A TX Onc - Southwest
state: Texas
city: Houston
country: United States
facility: Oncology Consultants Oncology Consultants, P.A.
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
state: Utah
city: Roanoke
country: United States
facility: Oncology Hematology Associates of Southeast Virginia Salem VA Branch
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
state: Washington
city: Morgantown
country: United States
facility: West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology
state: West Virginia
city: Green Bay
country: United States
facility: Cancer TEAM Bellin Health Belin Health
state: Wisconsin
city: Madison
country: United States
facility: Dean Health System Dean Hematology Oncology
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
state: Wisconsin
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: San Miguel De Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Rio Negro
country: Argentina
facility: Novartis Investigative Site
state: Viedma
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Woollongong
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: South Brisbane
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Murdoch
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Jette
country: Belgium
facility: Novartis Investigative Site
state: Brussel
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Namur
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Natal
country: Brazil
facility: Novartis Investigative Site
state: RN
city: Ijuí
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Barretos
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sorocaba
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Kelowna
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Cambridge
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Laval
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regina
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Shengyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Brno Bohunice
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Olomouc
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Nice Cedex 2
country: France
facility: Novartis Investigative Site
state: Alpes Maritimes
city: Dijon Cedex
country: France
facility: Novartis Investigative Site
state: Cote D Or
city: Saint Priest en Jarez
country: France
facility: Novartis Investigative Site
state: Loire
city: Angers Cedex 02
country: France
facility: Novartis Investigative Site
city: Avignon Cedex
country: France
facility: Novartis Investigative Site
city: Besancon cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Caen Cedex
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand
country: France
facility: Novartis Investigative Site
city: Le Mans Cedex
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Montpellier Cedex 5
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Rouen Cedex 1
country: France
facility: Novartis Investigative Site
city: Saint-Herblain Cédex
country: France
facility: Novartis Investigative Site
city: Strasbourg cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Langen
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Recklinghausen
country: Germany
facility: Novartis Investigative Site
state: North Rhine-westphalia
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-holstein
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Mühlhausen
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
city: Velbert
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
city: Patras
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Miskolc
country: Hungary
facility: Novartis Investigative Site
city: Szolnok
country: Hungary
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Cuneo
country: Italy
facility: Novartis Investigative Site
state: CN
city: Cremona
country: Italy
facility: Novartis Investigative Site
state: CR
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
state: CZ
city: Meldola
country: Italy
facility: Novartis Investigative Site
state: FC
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
state: LU
city: Macerata
country: Italy
facility: Novartis Investigative Site
state: MC
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Rimini
country: Italy
facility: Novartis Investigative Site
state: RN
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Mirano
country: Italy
facility: Novartis Investigative Site
state: VE
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Isehara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Sakyo Ku
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Koto ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho Gu
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Surquillo
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Kraków
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St- Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Parktown
country: South Africa
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Jaen
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Toledo
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Tarragona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Las Palmas De Gran Canarias
country: Spain
facility: Novartis Investigative Site
state: Las Palmas De Gran Canaria
city: San Sebastian de los Reyes
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Bellinzona
country: Switzerland
facility: Novartis Investigative Site
city: Genève
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Truro
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Bournemouth
country: United Kingdom
facility: Novartis Investigative Site
city: Derby
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortes J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaer S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J. Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2. Eur J Cancer. 2018 Nov;103:147-154. doi: 10.1016/j.ejca.2018.08.002. Epub 2018 Sep 18.
citation: Baselga J, Im SA, Iwata H, Cortes J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):904-916. doi: 10.1016/S1470-2045(17)30376-5. Epub 2017 May 30.