Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

PHASE3CompletedINTERVENTIONAL
Enrollment

726

Participants

Timeline

Start Date

June 9, 2015

Primary Completion Date

November 3, 2017

Study Completion Date

January 11, 2023

Conditions
Advanced Breast Cancer
Interventions
DRUG

Ribociclib

Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle.

DRUG

Fulvestrant

Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15.

DRUG

Placebo

Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle.

Trial Locations (174)

1134

Novartis Investigative Site, Budapest

1303

Novartis Investigative Site, Sofia

1606

Novartis Investigative Site, Sofia

1756

Novartis Investigative Site, Sofia

2065

Novartis Investigative Site, St Leonards

2730

Novartis Investigative Site, Herlev

3000

Novartis Investigative Site, Leuven

3002

Novartis Investigative Site, East Melbourne

3500

Novartis Investigative Site, Hasselt

4000

Novartis Investigative Site, Liège

4029

Novartis Investigative Site, Herston

4031

Novartis Investigative Site, Basel

4032

Novartis Investigative Site, Debrecen

5000

Novartis Investigative Site, Namur

Novartis Investigative Site, Aarau

6000

Novartis Investigative Site, Charleroi

6009

Novartis Investigative Site, Nedlands

6020

Novartis Investigative Site, Innsbruck

7100

Novartis Investigative Site, Vejle

8038

Novartis Investigative Site, Zurich

9300

Novartis Investigative Site, Aalst

10016

NYU Langone Med Center CV Research NYU Langone Medical Center, New York

10117

Novartis Investigative Site, Berlin

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10967

Novartis Investigative Site, Berlin

11042

Clinical Research Alliance ., Lake Success

11941

Novartis Investigative Site, Amman

12801

CR Wood Cancer Center SC, Glens Falls

12808

Novartis Investigative Site, Prague

15009

Novartis Investigative Site, A Coruña

17033

Penn State University Milton S Hershey Medical Center SC, Hershey

18014

Novartis Investigative Site, Granada

20089

Novartis Investigative Site, Rozzano

20133

Novartis Investigative Site, Milan

22081

Novartis Investigative Site, Hamburg

22767

Novartis Investigative Site, Hamburg

23538

Novartis Investigative Site, Lübeck

25030

Novartis Investigative Site, Besançon

25123

Novartis Investigative Site, Brescia

26121

Novartis Investigative Site, Oldenburg

28009

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Madrid

28702

Novartis Investigative Site, San Sebastián de los Reyes

28922

Novartis Investigative Site, Alcorcón

29010

Novartis Investigative Site, Málaga

29200

Novartis Investigative Site, Brest

30559

Novartis Investigative Site, Hanover

31792

John D Archbold Memorial Hospital Main, Thomasville

32804

Florida Hospital Cancer Institute SC, Orlando

32806

UF Health Cancer Center at Orlando Health, Orlando

33000

Novartis Investigative Site, Bordeaux

33076

Novartis Investigative Site, Bordeaux

33328

Florida Cancer Research Institute Dept of Oncology, Davie

33604

Novartis Investigative Site, Bielefeld

34303

Novartis Investigative Site, Istanbul

34381

Novartis Investigative Site, Istanbul

34662

Novartis Investigative Site, Istanbul

35575

Novartis Investigative Site, Izmir

36608

Southern Cancer Center PC SC-2, Mobile

37007

Novartis Investigative Site, Salamanca

39202

Jackson Oncology Associates SC, Jackson

41014

Novartis Investigative Site, Seville

42551

Novartis Investigative Site, Velbert

43701

Genesis Cancer Services SC, Zanesville

46063

Novartis Investigative Site, Liberec

49124

Novartis Investigative Site, Georgsmarienhütte

50935

Novartis Investigative Site, Cologne

51056

Novartis Investigative Site, Reims

53111

Novartis Investigative Site, Bonn

53840

Novartis Investigative Site, Troisdorf

56025

Novartis Investigative Site, Pontedera

59020

Novartis Investigative Site, Lille

63225

Novartis Investigative Site, Langen

65653

Novartis Investigative Site, Brno

66113

Novartis Investigative Site, Saarbrücken

67000

Novartis Investigative Site, Strasbourg

67100

Novartis Investigative Site, L’Aquila

68000

Novartis Investigative Site, Oaxaca City

69115

Novartis Investigative Site, Heidelberg

69495

Novartis Investigative Site, Pierre-Bénite

72015

Novartis Investigative Site, Le Mans

72076

Novartis Investigative Site, Tübingen

72703

Highlands Oncology Group ., Fayetteville

73100

Novartis Investigative Site, Lecce

75651

Novartis Investigative Site, Paris

77090

Millennium Research Clin Develop SC, Houston

80131

Novartis Investigative Site, Napoli

80528

Poudre Valley Hospital, Fort Collins

80637

Novartis Investigative Site, München

81100

Novartis Investigative Site, Johor Bahru

83056

Novartis Investigative Site, Toulon La Seyne Sur Mer

85224

Ironwood Cancer and Research Centers SC-2, Chandler

86150

Novartis Investigative Site, Augsburg

87000

Novartis Investigative Site, Limoges

87131

University of New Mexico Cancer Center SC, Albuquerque

88214

Novartis Investigative Site, Ravensburg

90095

UCLA Medical Center ., Los Angeles

90766

Novartis Investigative Site, Fürth

91054

Novartis Investigative Site, Erlangen

92210

Novartis Investigative Site, Saint-Cloud

92637

Novartis Investigative Site, Weiden

93454

Central Coast Medical Oncology Corporation SC, Santa Maria

93586

Novartis Investigative Site, Kuching

94000

Novartis Investigative Site, Créteil

94503

St Joseph Heritage Healthcare, Santa Rosa

95124

Novartis Investigative Site, Catania

96817

Moanalua Medical Center. Attn: Oncology Dept SC, Honolulu

98101

Virginia Mason Medical Center-Oncology SC, Seattle

98201

Providence Regional Cancer Partnership ., Everett

98503

Providence Regional Cancer System SC, Lacey

99974

Novartis Investigative Site, Mühlhausen

110221

Novartis Investigative Site, Bogotá

119228

Novartis Investigative Site, Singapore

163045

Novartis Investigative Site, Arkhangelsk

166830

Novartis Investigative Site, El Achrafiyé

230004

Novartis Investigative Site, Montería

392000

Novartis Investigative Site, Tambov

60068-0736

Oncology Specialists, SC Advocate Medical Group-Niles, Park Ridge

07753

Meridian Health Systems Regulatory, Neptune City

84403-3105

Northern Utah Cancer Associates CFTY720DUS01, Ogden

A-1090

Novartis Investigative Site, Vienna

A-1100

Novartis Investigative Site, Vienna

V3V 1Z2

Novartis Investigative Site, Surrey

V5Z 4E6

Novartis Investigative Site, Vancouver

V8R 6V5

Novartis Investigative Site, Victoria

E1C 8X3

Novartis Investigative Site, Moncton

B3H 1V7

Novartis Investigative Site, Halifax

L6R 3J7

Novartis Investigative Site, Brampton

K7L 5P9

Novartis Investigative Site, Kingston

J7Y 2P9

Novartis Investigative Site, Newmarket

H3G 1L5

Novartis Investigative Site, Montreal

G5L 5T1

Novartis Investigative Site, Rimouski

J1H 5N4

Novartis Investigative Site, Sherbrooke

G8Z 3R9

Novartis Investigative Site, Trois-Rivières

625 00

Novartis Investigative Site, Brno Bohunice

180 81

Novartis Investigative Site, Prague

DK 9000

Novartis Investigative Site, Aalborg

DK-8000

Novartis Investigative Site, Aarhus

DK-2100

Novartis Investigative Site, Copenhagen

DK 5000

Novartis Investigative Site, Odense C

01307

Novartis Investigative Site, Dresden

H 1122

Novartis Investigative Site, Budapest

H-1032

Novartis Investigative Site, Budapest

H-5000

Novartis Investigative Site, Szolnok

1107 2020

Novartis Investigative Site, Beirut

1066 CX

Novartis Investigative Site, Amsterdam

4819 EV

Novartis Investigative Site, Breda

7416 SE

Novartis Investigative Site, Deventer

7513 ER

Novartis Investigative Site, Enschede

9728 NZ

Novartis Investigative Site, Groningen

2134 TM

Novartis Investigative Site, Hoofddorp

6229 HX

Novartis Investigative Site, Maastricht

3435 CM

Novartis Investigative Site, Nieuwegein

6043 CV

Novartis Investigative Site, Roermond

6162 BG

Novartis Investigative Site, Sittard-Geleen

2545 CH

Novartis Investigative Site, The Hague

5042 AD

Novartis Investigative Site, Tilburg

NO 0424

Novartis Investigative Site, Oslo

62 500

Novartis Investigative Site, Konin

04-125

Novartis Investigative Site, Warsaw

1400-038

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08970

Novartis Investigative Site, Sant Joan Despí

08036

Novartis Investigative Site, Barcelona

SE-631 88

Novartis Investigative Site, Eskilstuna

851 86

Novartis Investigative Site, Sundsvall

SE-351 85

Novartis Investigative Site, Vaxjo

PL6 8DH

Novartis Investigative Site, Plymouth

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY