Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

PHASE3CompletedINTERVENTIONAL
Enrollment

572

Participants

Timeline

Start Date

July 23, 2015

Primary Completion Date

June 12, 2018

Study Completion Date

June 9, 2023

Conditions
Breast Cancer
Interventions
DRUG

Fulvestrant

500 mg of fulvestrant administered via intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle

DRUG

Alpelisib

300 mg of alpelisib tablets for oral use administered once daily

DRUG

Placebo

300 mg of placebo tablets for oral use administered once daily

Trial Locations (197)

34

Novartis Investigative Site, Surquillo

41

Novartis Investigative Site, San Borja

652

Novartis Investigative Site, Saida

1000

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Vienna

Novartis Investigative Site, Brussels

1134

Novartis Investigative Site, Budapest

1340

Novartis Investigative Site, Ottignies

1756

Novartis Investigative Site, Sofia

2076

Novartis Investigative Site, Wahroonga

2650

Novartis Investigative Site, Edegem

3000

Novartis Investigative Site, Melbourne

4004

Novartis Investigative Site, Plovdiv

4010

Novartis Investigative Site, Linz

4102

Novartis Investigative Site, Wooloongabba

4400

Novartis Investigative Site, Nyíregyháza

4800

Novartis Investigative Site, Verviers

5112

Novartis Investigative Site, Elizabeth Vale

5300

Novartis Investigative Site, La Rioja

5801

Novartis Investigative Site, Venray

6800

Novartis Investigative Site, Libramont

7100

Novartis Investigative Site, Szekszárd

8500

Novartis Investigative Site, Rio Negro

9002

Novartis Investigative Site, Varna

9010

Novartis Investigative Site, Varna

9100

Novartis Investigative Site, Sint-Niklaas

10002

Novartis Investigative Site, Taipei

10003

Novartis Investigative Site, Cáceres

10126

Novartis Investigative Site, Torino

10330

Novartis Investigative Site, Bangkok

10408

Novartis Investigative Site, Gyeonggi-do

10700

Novartis Investigative Site, Bangkok

10999

Novartis Investigative Site, Beirut

11217

Novartis Investigative Site, Taipei

11407

Novartis Investigative Site, Jerez de la Frontera

11528

Novartis Investigative Site, Athens

12002

Novartis Investigative Site, Castellon

13620

Novartis Investigative Site, Bundang Gu

13915

Novartis Investigative Site, Marseille

14021

Novartis Investigative Site, Caen

14467

Novartis Investigative Site, Potsdam

15706

Novartis Investigative Site, Santiago de Compostela

17100

Novartis Investigative Site, Savona

17604

Lancaster General Hospital, Lancaster

18059

Novartis Investigative Site, Rostock

18547

Novartis Investigative Site, Athens

20133

Novartis Investigative Site, Milan

21202

Mercy Medical Center, Baltimore

22031

Virginia Cancer Specialists, Fairfax

23563

Novartis Investigative Site, Lübeck

24105

Novartis Investigative Site, Kiel

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

28223

Novartis Investigative Site, Pozuelo de Alarcón

29615

Prisma Health Upstate, Greenville

30029

Novartis Investigative Site, Nîmes

30120

Novartis Investigative Site, El Palmar

30625

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

33081

Novartis Investigative Site, Aviano

33705

Florida Cancer Specialists-North, St. Petersburg

33901

Florida Cancer Specialists, Fort Myers

34070

Novartis Investigative Site, Montpellier

35100

Novartis Investigative Site, Padua

37024

Novartis Investigative Site, Negrar

37203

SCRI Oncology Partners, Nashville

38320

Novartis Investigative Site, San Cristóbal de La Laguna

41013

Novartis Investigative Site, Seville

42551

Novartis Investigative Site, Velbert

44106

University Hospitals of Cleveland Seidman Cancer Center, Cleveland

44805

Novartis Investigative Site, Saint-Herblain

45657

Novartis Investigative Site, Recklinghausen

46010

Novartis Investigative Site, Valencia

46815

Fort Wayne Medical Oncology Hematology Inc, Fort Wayne

47014

Novartis Investigative Site, Meldola

48867

Detroit Clinical Research Center, Owosso

49055

Novartis Investigative Site, Angers

52621

Novartis Investigative Site, Ramat Gan

55131

Novartis Investigative Site, Mainz

56025

Novartis Investigative Site, Pontedera

57105

Avera Cancer, Sioux Falls

59102

St Vincent Frontier Cancer Center, Billings

60126

Novartis Investigative Site, Ancona

60201

NorthShore University Health System, Evanston

60389

Novartis Investigative Site, Frankfurt

60540

Edward Cancer Center, Naperville

60612

Rush University Medical Center, Chicago

63011

Novartis Investigative Site, Clermont-Ferrand

63739

Novartis Investigative Site, Aschaffenburg

64111

St Lukes Cancer Institute, Kansas City

64320

Novartis Investigative Site, Monterrey

66100

Novartis Investigative Site, Chieti

66421

Novartis Investigative Site, Homburg

69373

Novartis Investigative Site, Lyon 08

70185

Novartis Investigative Site, Örebro

72703

Highlands Oncology Group, Fayetteville

75231

Texas Oncology PA Dallas Presbyterian Hospital, Dallas

75702

Texas Oncology Northeast Texas, Tyler

76038

Novartis Investigative Site, Rouen

78150

Novartis Investigative Site, Le Chesnay

78200

Novartis Investigative Site, San Luis Potosí City

78229

Mays Cancer Ctr Uthsa Mdacc, San Antonio

79902

El Paso Texas Oncology, El Paso

84082

Novartis Investigative Site, Avignon

85028

Novartis Investigative Site, Rionero in Vulture

85224

Ironwood Cancer and Research Centers, Chandler

85259

Mayo Clinic Arizona, Scottsdale

85925

Novartis Investigative Site, La Roche-sur-Yon

88045

Novartis Investigative Site, Friedrichshafen

89081

Novartis Investigative Site, Ulm

90127

Novartis Investigative Site, Palermo

90211

Beverly Hills Cancer Center, Beverly Hills

92037

Scripps Green Hospital, La Jolla

92120

Kaiser Permanent Southern Californi, San Diego

92309

Novartis Investigative Site, Levallois-Perret

94010

Novartis Investigative Site, Créteil

94115

UCSF, San Francisco

94800

Novartis Investigative Site, Villejuif

97330

Good Samaritan Regional Medical Center, Corvallis

98801

Wenatchee Valley Medical Center, Wenatchee

163045

Novartis Investigative Site, Arkhangelsk

166830

Novartis Investigative Site, El Achrafiyé

197758

Novartis Investigative Site, Saint Petersburg

200347

Novartis Investigative Site, Craiova

390011

Novartis Investigative Site, Ryazan

407280

Novartis Investigative Site, Floreşti

440010

Novartis Investigative Site, Nagpur

520002

Novartis Investigative Site, Vijayawada

700483

Novartis Investigative Site, Iași

2520612

Novartis Investigative Site, Viña del Mar

3109601

Novartis Investigative Site, Haifa

4810469

Novartis Investigative Site, Temuco

4941492

Novartis Investigative Site, Petah Tikva

6423906

Novartis Investigative Site, Tel Aviv

8420383

Novartis Investigative Site, Santiago

8457108

Novartis Investigative Site, Beersheba

91010 3000

City of Hope National Medical Center, Duarte

66606-169

St Francis Health Comprehensive Cancer Center, Topeka

02114

Massachusetts General Hospital, Boston

01805

Lahey Clinic, Burlington

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

B1884BBF

Novartis Investigative Site, Berazategui

C1125ABD

Novartis Investigative Site, CABA

59075 740

Novartis Investigative Site, Natal

95900-000

Novartis Investigative Site, Lajeado

04014-002

Novartis Investigative Site, São Paulo

15090 000

Novartis Investigative Site, São José do Rio Preto

01236 030

Novartis Investigative Site, São Paulo

T2N 4N2

Novartis Investigative Site, Calgary

N1R 3G2

Novartis Investigative Site, Cambridge

K1H 8L6

Novartis Investigative Site, Ottawa

M5B 1W8

Novartis Investigative Site, Toronto

G1S 4L8

Novartis Investigative Site, Québec

140 46

Novartis Investigative Site, Prague

762 75

Novartis Investigative Site, Zlín

500 05

Novartis Investigative Site, Hradec Králové

180 00

Novartis Investigative Site, Prague

04277

Novartis Investigative Site, Leipzig

564 29

Novartis Investigative Site, Thessaloniki

Unknown

Novartis Investigative Site, Pokfulam

H 1122

Novartis Investigative Site, Budapest

400 012

Novartis Investigative Site, Mumbai

00168

Novartis Investigative Site, Roma

07100

Novartis Investigative Site, Sassari

464 8681

Novartis Investigative Site, Nagoya

791-0280

Novartis Investigative Site, Matsuyama

371 8511

Novartis Investigative Site, Maebashi

003-0804

Novartis Investigative Site, Sapporo

673-8558

Novartis Investigative Site, Akashi

259-1193

Novartis Investigative Site, Isehara

241-8515

Novartis Investigative Site, Yokohama

540-0006

Novartis Investigative Site, Osaka

541-8567

Novartis Investigative Site, Osaka

362-0806

Novartis Investigative Site, Kitaadachi-gun

104 8560

Novartis Investigative Site, Chuo Ku

105-8470

Novartis Investigative Site, Minato Ku

892-0833

Novartis Investigative Site, Kagoshima

860-8556

Novartis Investigative Site, Kumamoto

4535 PA

Novartis Investigative Site, Terneuzen

LIMA 27

Novartis Investigative Site, Lima

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

07120

Novartis Investigative Site, Palma de Mallorca

08916

Novartis Investigative Site, Badalona

08024

Novartis Investigative Site, Barcelona

06080

Novartis Investigative Site, Badajoz

03010

Novartis Investigative Site, Alicante

SE-801 87

Novartis Investigative Site, Gävle

721 89

Novartis Investigative Site, Västerås

LE1 5WW

Novartis Investigative Site, Leicester

SE1 9RT

Novartis Investigative Site, London

PL6 8DH

Novartis Investigative Site, Plymouth

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY