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

Breast Cancer Clinical Trial

— BELLE-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610284
• Other study ID #: CBKM120F2302
• Secondary ID: 2011-005524-17
• Status: Completed
• Phase: Phase 3
• Start date: August 7, 2012
• Est. completion date: April 19, 2019

Study information

• Verified date: August 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1147
• Est. completion date: April 19, 2019
• Est. primary completion date: April 29, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fulvestrant
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
• BKM120
BKM120 100 mg once daily
• BKM120 matching placebo
BKM120 matching placebo, once daily

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Rio Negro	Viedma
Argentina	Novartis Investigative Site	San Miguel De Tucuman	Tucuman
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	South Brisbane	Queensland
Australia	Novartis Investigative Site	Sydney	New South Wales
Australia	Novartis Investigative Site	Woollongong	New South Wales
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Charleroi
Belgium	Novartis Investigative Site	Jette	Brussel
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Namur
Belgium	Novartis Investigative Site	Wilrijk
Brazil	Novartis Investigative Site	Barretos	SP
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Ijuí	RS
Brazil	Novartis Investigative Site	Natal	RN
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sorocaba	SP
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Cambridge	Ontario
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Kelowna	British Columbia
Canada	Novartis Investigative Site	Laval	Quebec
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Regina	Saskatchewan
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shengyang	Liaoning
Czechia	Novartis Investigative Site	Brno
Czechia	Novartis Investigative Site	Brno Bohunice	Czech Republic
Czechia	Novartis Investigative Site	Olomouc	CZE
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	Dijon Cedex	Cote D Or
France	Novartis Investigative Site	Le Mans Cedex
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Montpellier Cedex 5
France	Novartis Investigative Site	Nice Cedex 2	Alpes Maritimes
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Rouen Cedex 1
France	Novartis Investigative Site	Saint Priest en Jarez	Loire
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
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	Langen	Hessen
Germany	Novartis Investigative Site	Luebeck	Schleswig-holstein
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	Recklinghausen	North Rhine-westphalia
Germany	Novartis Investigative Site	Saarbruecken
Germany	Novartis Investigative Site	Velbert
Germany	Novartis Investigative Site	Wuerzburg
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Heraklion Crete
Greece	Novartis Investigative Site	Patras
Greece	Novartis Investigative Site	Thessaloniki	GR
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Miskolc
Hungary	Novartis Investigative Site	Szolnok
Israel	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
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Catanzaro	CZ
Italy	Novartis Investigative Site	Cremona	CR
Italy	Novartis Investigative Site	Cuneo	CN
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Lido di Camaiore	LU
Italy	Novartis Investigative Site	Macerata	MC
Italy	Novartis Investigative Site	Meldola	FC
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	Mirano	VE
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Rimini	RN
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Torino	TO
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Isehara	Kanagawa
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Koto ku	Tokyo
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Maebashi city	Gunma
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Sakyo Ku	Kyoto
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Suita city	Osaka
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
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	Suwon	Gyeonggi-do
Netherlands	Novartis Investigative Site	Nijmegen
Peru	Novartis Investigative Site	Surquillo	Lima
Poland	Novartis Investigative Site	Kraków
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Warszawa
Russian Federation	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
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
South Africa	Novartis Investigative Site	Johannesburg
South Africa	Novartis Investigative Site	Parktown
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	Barcelona
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	El Palmar	Murcia
Spain	Novartis Investigative Site	Elche	Alicante
Spain	Novartis Investigative Site	Jaen	Andalucia
Spain	Novartis Investigative Site	Las Palmas De Gran Canarias	Las Palmas De Gran Canaria
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	Malaga	Andalucia
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	San Sebastian de los Reyes	Madrid
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Tarragona	Cataluña
Spain	Novartis Investigative Site	Toledo	Castilla La Mancha
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	Zaragoza
Switzerland	Novartis Investigative Site	Bellinzona
Switzerland	Novartis Investigative Site	Genève
Switzerland	Novartis Investigative Site	Zuerich
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
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	Novartis Investigative Site	Truro	Cornwall
United States	Shapiro and Stafford and Yee and Polanski Study Coordinator	Arcadia	California
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	St. Luke's Hospital and Health Network St Luke's (2)	Bethlehem	Pennsylvania
United States	Massachusetts General Hospital SC	Boston	Massachusetts
United States	Hackensack Meridian Health	Brick	New Jersey
United States	Charleston Hematology Oncology Association PA	Charleston	South Carolina
United States	Levine Cancer Institute Levine Cancer Institute	Charlotte	North Carolina
United States	Case Western Reserve SC	Cleveland	Ohio
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	Georgia Cancer Specialists SC	Decatur	Georgia
United States	Kaiser Permanente Northwest Kaiser	Denver	Colorado
United States	North Shore University Health System	Evanston	Illinois
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Frederick Memorial Hospital Fred. Mem. Hosp.	Frederick	Maryland
United States	Cancer Care Associates Dept.ofCancerCareAssoc.	Fresno	California
United States	St. Jude Heritage Medical Group Virginia Crosson Cancer Center	Fullerton	California
United States	Cadence Health	Geneva	Illinois
United States	Cancer TEAM Bellin Health Belin Health	Green Bay	Wisconsin
United States	Rocky Mountain Cancer Centers RMCC	Greenwood Village	Colorado
United States	Memorial Regional Cancer Center MRCC	Hollywood	Florida
United States	Oncology Consultants Oncology Consultants, P.A.	Houston	Texas
United States	Cancer Specialists of North Florida SC - F2302	Jacksonville	Florida
United States	West Michigan Cancer Center Dept of Oncology	Kalamazoo	Michigan
United States	Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc	Kennewick	Washington
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	University of California San Diego - Moores Cancer Center UCSD 3	La Jolla	California
United States	Clinical Research Alliance SC-2	Lake Success	New York
United States	Los Angeles Hematology/Oncology Medical Group LA Cancer Network	Los Angeles	California
United States	University of California at Los Angeles Dept. of UCLA	Los Angeles	California
United States	USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)	Los Angeles	California
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	University of Miami Univ Miami 2	Miami	Florida
United States	University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)	Mobile	Alabama
United States	West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology	Morgantown	West Virginia
United States	Cancer Care and Hematology Specialists of Chicagoland Niles	Multiple Locations	Illinois
United States	Vanderbilt University Medical Center Vanderbilt - Thompson Ln	Nashville	Tennessee
United States	Memorial Sloan Kettering Dept Onc	New York	New York
United States	MD Anderson Cancer Center - Orlando MD Orlando	Orlando	Florida
United States	Ventura County Hematology and Oncology PMK Medical Group	Oxnard	California
United States	The Valley Hospital / Luckow Pavillion	Paramus	New Jersey
United States	Arizona Oncology Associates Dept of Oncology	Phoenix	Arizona
United States	Northwest Cancer Specialists Portland Loc	Portland	Oregon
United States	Oncology Hematology Associates of Southeast Virginia Salem VA Branch	Roanoke	Virginia
United States	University of Rochester Medical Center Univ Rochester	Rochester	New York
United States	Maryland Oncology Hematology, P.A. SC	Rockville	Maryland
United States	Washington University School of Medicine Regulatory	Saint Louis	Missouri
United States	Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)	Salt Lake City	Utah
United States	Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development	San Antonio	Texas
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	Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint	Tupelo	Mississippi
United States	Granada Hills Cancer Center	Valencia	California
United States	Cancer Center of Kansas CCK	Wichita	Kansas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Peru,  Poland,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort	Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.	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	Overall Survival (OS) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort	Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up for the duration of the study and for an expected average of every 3 months after end of treatment.	Every 3 months following end of treatment visit, assessed for approximately 5 years
Secondary	Overall Response Rate (ORR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort	Overall Response Rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1. ORR was analyzed in the full population. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target/non target lesions: Complete Response (CR), disappearance of all target/non target lesions (all lymph nodes assigned as non-target lesions must be non-pathological in size (< 10 mm short axis)); Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions ; Overall Response (OR)= CR+PR. Only descriptive analysis performed.	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
Secondary	Clinical Benefit Rate (CBR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort	Clinical Benefit Rate (CBR) is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population. Only descriptive analysis performed.	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
Secondary	Number of Participants With On-Treatments Adverse Events, Serious Adverse Events and Deaths	Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths. Only descriptive analysis performed.	From first dose of study treatment to 30 days after last dose of study treatment, assessed for approximately 5 years
Secondary	Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 2 Day 1	Plasma samples were collected from the first 200 BKM120-treated patients on Cycle 2 Day 1 (at pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h and 24h [before Cycle 2 Day 2 dose] post-dose). Each cycle is 28 days. Only descriptive analysis performed.	Cycle2 Day1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose). Each cycle is 28 days.
Secondary	Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)	Pre-dose samples were collected for trough concentrations at Cycle 2 Day 1, Cycle 2 Day 15 and Cycle 3 Day 1. Each cycle is 28 days. Only descriptive analysis performed.	Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1. Each cycle is 28 days.
Secondary	Median Time to Definitive Deterioration of the ECOG Performance Status - Full Analysis Set (FAS)	Time to definitive deterioration of the ECOG PS was defined as the time between the date of randomization and the date of the assessment at which definitive deterioration was seen. Only descriptive analysis performed.	Up to approx 27 months
Secondary	Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30	The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is defined as the time from the randomization date to the date of an event, which is defined as a worsening (decrease) in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study or death due to any cause. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high /healthy level of functioning, a high score for the global health status / QoL represents a high QoL. Patients were assessed up to approx. 8.3 months. Only descriptive analysis performed.	Cycle 1 day 1, cycle 1 day 15, 6 weeks after randomisation and then every 8 weeks until end of treatment