A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

5,101

Participants

Timeline

Start Date

December 7, 2018

Primary Completion Date

May 29, 2026

Study Completion Date

May 29, 2026

Conditions
Early Breast Cancer
Interventions
DRUG

Ribociclib

Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle

OTHER

Endocrine Therapy

ET will be administered according to the local clinical guidelines and current local prescribing information

Trial Locations (387)

1000

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Vienna

Novartis Investigative Site, Jette

1200

Novartis Investigative Site, Brussels

2010

Novartis Investigative Site, Darlinghurst

2065

Novartis Investigative Site, St Leonards

2076

Novartis Investigative Site, Wahroonga

2109

Novartis Investigative Site, North Ryde

2145

Novartis Investigative Site, Westmead

2170

Novartis Investigative Site, Liverpool

2217

Novartis Investigative Site, Kogarah

2450

Novartis Investigative Site, Coffs Harbour

2560

Novartis Investigative Site, Campbelltown

2610

Novartis Investigative Site, Wilrijk

2650

Novartis Investigative Site, Edegem

2747

Novartis Investigative Site, Kingswood

3000

Novartis Investigative Site, Melbourne

Novartis Investigative Site, Leuven

3002

Novartis Investigative Site, East Melbourne

3065

Novartis Investigative Site, Fitzroy

3076

Novartis Investigative Site, Epping

3084

Novartis Investigative Site, Heidelberg

3199

Novartis Investigative Site, Franston

3500

Novartis Investigative Site, Hasselt

3550

Novartis Investigative Site, Bendigo

3630

Novartis Investigative Site, Shepparton

4000

Novartis Investigative Site, Liège

4020

Novartis Investigative Site, Linz

4032

Novartis Investigative Site, Debrecen

4066

Novartis Investigative Site, Auchenflower

4102

Novartis Investigative Site, Wooloongabba

4575

Novartis Investigative Site, Birtinya

4600

Novartis Investigative Site, San Salvador de Jujuy

5000

Novartis Investigative Site, Namur

5020

Novartis Investigative Site, Salzburg

5041

Novartis Investigative Site, Bedford Park

5300

Novartis Investigative Site, La Rioja

5530

Novartis Investigative Site, Yvoir

6000

Novartis Investigative Site, Charleroi

6001

Novartis Investigative Site, Kecskemét

6009

Novartis Investigative Site, Nedlands

6020

Novartis Investigative Site, Innsbruck

6150

Novartis Investigative Site, Murdoch

6720

Novartis Investigative Site, Szeged

6800

Novartis Investigative Site, Libramont

7100

Novartis Investigative Site, Szekszárd

7623

Novartis Investigative Site, Pécs

8036

Novartis Investigative Site, Graz

8500

Novartis Investigative Site, Rio Negro

8900

Novartis Investigative Site, Zalaegerszeg

10002

Novartis Investigative Site, Taipei

10003

Novartis Investigative Site, Cáceres

10016

Perlmutter Cancer Centre, New York

10060

Novartis Investigative Site, Candiolo

10408

Novartis Investigative Site, Gyeonggi-do

10449

Novartis Investigative Site, Taipei

11217

Novartis Investigative Site, Taipei

12002

Novartis Investigative Site, Castellon

13008

Novartis Investigative Site, Marseille

13125

Novartis Investigative Site, Berlin

13620

Novartis Investigative Site, Bundang Gu

14004

Novartis Investigative Site, Córdoba

14021

Novartis Investigative Site, Caen

15006

Novartis Investigative Site, A Coruña

15009

Novartis Investigative Site, A Coruña

16499

Novartis Investigative Site, Suwon

17007

Novartis Investigative Site, Girona

17033

Penn State Hershey Cancer Institute, Hershey

18014

Novartis Investigative Site, Granada

18016

Novartis Investigative Site, Granada

19124

Cancer Treatment Centers of America Eastern Regional Medical Center, Philadelphia

20080

Novartis Investigative Site, Donostia / San Sebastian

20089

Novartis Investigative Site, Rozzano

20133

Novartis Investigative Site, Milan

20357

Novartis Investigative Site, Hamburg

21005

Novartis Investigative Site, Huelva

21034

Novartis Investigative Site, Dijon

21202

Mercy Medical Center, Baltimore

22031

Virginia Cancer Specialists, Fairfax

22332

Novartis Investigative Site, Incheon

23007

Novartis Investigative Site, Jaén

23230

Virginia Cancer Institute, Richmond

24105

Novartis Investigative Site, Kiel

24127

Novartis Investigative Site, Bergamo

25030

Novartis Investigative Site, Besançon

26426

Novartis Investigative Site, Wŏnju

27003

Novartis Investigative Site, Lugo

27204

Randolph Medical Associates, Asheboro

27403

Cone Health Cancer Center, Greensboro

28009

Novartis Investigative Site, Madrid

28033

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Majadahonda

28644

Novartis Investigative Site, Cheongju-si

28942

Novartis Investigative Site, Fuenlabrada

29010

Novartis Investigative Site, Málaga

30008

Novartis Investigative Site, Murcia

30120

Novartis Investigative Site, El Palmar

30177

Novartis Investigative Site, Hanover

30265

Southeastern Regional Medical Center, Newnan

30322

Winship Cancer Institute of Emory University, Atlanta

31008

Novartis Investigative Site, Pamplona

31059

Novartis Investigative Site, Toulouse

31501

Novartis Investigative Site, Krakow

32207

Baptist MD Anderson Cancer Center, Jacksonville

32308

Florida Cancer Specialists Pan, Tallahassee

32806

Orlando Health Clinical Trials, Orlando

33021

Memorial Cancer Institute, Hollywood

33076

Novartis Investigative Site, Bordeaux

33081

Novartis Investigative Site, Aviano

33136

University of Miami, Miami

33305

Novartis Investigative Site, Taoyuan District

33308

Holy Cross Hospital-Ft. Lauderdale, Fort Lauderdale

33401

Florida Cancer Specialists, West Palm Beach

33705

Florida Cancer Specialists-North, St. Petersburg

33901

Florida Cancer Specialists, Fort Myers

34070

Novartis Investigative Site, Montpellier

34298

Novartis Investigative Site, Montpellier

35010

Novartis Investigative Site, Las Palmas GC

35062

Novartis Investigative Site, Rennes

36212

Novartis Investigative Site, Vigo

37007

Novartis Investigative Site, Salamanca

37203

Sarah Cannon Research Institute, Nashville

38028

Novartis Investigative Site, Grenoble

38138

The West Clinic, Germantown

38320

Novartis Investigative Site, San Cristóbal de La Laguna

40138

Novartis Investigative Site, Bologna

40202

Norton Cancer Institute, Louisville

40447

Novartis Investigative Site, Taichung

41009

Novartis Investigative Site, Seville

41013

Novartis Investigative Site, Seville

41061

Novartis Investigative Site, Mönchengladbach

41404

Novartis Investigative Site, Seoul

42551

Novartis Investigative Site, Velbert

44033

Novartis Investigative Site, Ulsan

44202

Novartis Investigative Site, Nantes

44805

Novartis Investigative Site, Saint-Herblain

45136

Novartis Investigative Site, Essen

45147

Novartis Investigative Site, Essen

46009

Novartis Investigative Site, Valencia

46010

Novartis Investigative Site, Valencia

46014

Novartis Investigative Site, Valencia

46236

Novartis Investigative Site, Bottrop

47150

Cancer Care Center, New Albany

48013

Novartis Investigative Site, Bilbao

48109

University of Michigan Cancer Center, Ann Arbor

48149

Novartis Investigative Site, Münster

48346

Novartis Investigative Site, Waterford

49055

Novartis Investigative Site, Angers

49124

Novartis Investigative Site, Georgsmarienhütte

50006

Novartis Investigative Site, Changhua

50009

Novartis Investigative Site, Zaragoza

53111

Novartis Investigative Site, Bonn

54519

Novartis Investigative Site, Vandœuvre-lès-Nancy

55131

Novartis Investigative Site, Mainz

55369

Fairview Health Services, Maple Grove

55416

Metro Minnesota CCOP, Saint Louis Park

Park Nicollet Institute, Saint Louis Park

59102

St Vincent Frontier Cancer Center, Billings

60099

Cancer Treatment Centers of America, Zion

60126

Novartis Investigative Site, Ancona

60431

Novartis Investigative Site, Frankfurt am Main

63141

David C Pratt Cancer Center, St Louis

64111

Saint Lukes Hospital of Kansas City, Kansas City

64132

HCA Midwest Division, Kansas City

66205

University of Kansas Cancer Center, Westwood

68167

Novartis Investigative Site, Mannheim

68803

Saint Francis Medical Center, Grand Island

69004

Novartis Investigative Site, Lyon

69495

Novartis Investigative Site, Pierre-Bénite

69677

Novartis Investigative Site, Bron

70403

Novartis Investigative Site, Tainan City

72000

Novartis Investigative Site, Le Mans

72076

Novartis Investigative Site, Tübingen

72401

St Bernards Medical Center, Jonesboro

75013

Novartis Investigative Site, Paris

75015

Novartis Investigative Site, Paris

75231

Novartis Investigative Site, Paris

75246

Baylor Charles A Sammons Cancer Cnt, Dallas

75475

Novartis Investigative Site, Paris

75970

Novartis Investigative Site, Paris

76038

Novartis Investigative Site, Rouen

76104

Ctr For Cancer And Blood Disorders, Fort Worth

77030

MD Anderson Cancer Center University of Texas, Houston

80000

Novartis Investigative Site, Amiens

80045

University Of Colorado Hospital, Aurora

80131

Novartis Investigative Site, Napoli

80218

Rocky Mountain Cancer Centers, Denver

80637

Novartis Investigative Site, Munich

81377

Novartis Investigative Site, Munich

81675

Novartis Investigative Site, Munich

84082

Novartis Investigative Site, Avignon

84106

Utah Cancer Specialists, Salt Lake City

85338

Cancer Treatment Centers of America, Goodyear

86150

Novartis Investigative Site, Augsburg

87000

Novartis Investigative Site, Limoges

88212

Novartis Investigative Site, Ravensburg

89052

Comprehensive Cancer Cntr Of Nevada, Henderson

89081

Novartis Investigative Site, Ulm

90057

Southern CA Oncology Rsrch Alliance, Los Angeles

90146

Novartis Investigative Site, Palermo

90212

UCLA Beverly Hills, Beverly Hills

90277

Cancer Care Associates Medical Grp, Redondo Beach

90404

UCLA Santa Monica Hematology Oncology, Santa Monica

91054

Novartis Investigative Site, Erlangen

91326

UCLA Porter Ranch Hemato and Onco, Porter Ranch

91355

UCLA Valencia, Valencia

91361

UCLA Cancer Center Westlake Village, Westlake Village

91405

Valley Breast Care, Van Nuys

91436

Encino Research Center, Encino

91505

UCLA Burbank, Burbank

92123

Sharp Memorial Hospital, San Diego

92210

Novartis Investigative Site, Saint-Cloud

92653

UCLA Hematology Oncology, Laguna Hills

92835

St. Jude Heritage Medical Group, Fullerton

93053

Novartis Investigative Site, Regensburg

93309

Comprehensive Blood and Cancer, Bakersfield

93454

Central Coast Medical Oncology Corporation, Santa Maria

94115

UCSF, San Francisco

94800

Novartis Investigative Site, Villejuif

95107

Novartis Investigative Site, Argenteuil

95123

Novartis Investigative Site, Catania

97015

Kaiser Permanente NW Region, Clackamas

97080

Novartis Investigative Site, Würzburg

97422

Novartis Investigative Site, Schweinfurt

98109

Fred Hutchinson Cancer Center, Seattle

100021

Novartis Investigative Site, Beijing

103616

Novartis Investigative Site, Taipei

111123

Novartis Investigative Site, Moscow

115522

Novartis Investigative Site, Moscow

130021

Novartis Investigative Site, Changchun

143423

Novartis Investigative Site, Moscow

150054

Novartis Investigative Site, Yaroslavl

150081

Novartis Investigative Site, Harbin

156005

Novartis Investigative Site, Kostroma

191104

Novartis Investigative Site, Saint Petersburg

195271

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

198255

Novartis Investigative Site, Saint Petersburg

200032

Novartis Investigative Site, Shanghai

200347

Novartis Investigative Site, Craiova

200535

Novartis Investigative Site, Craiova

210029

Novartis Investigative Site, Nanjing

215004

Novartis Investigative Site, Suzhou

249036

Novartis Investigative Site, Obninsk

300425

Novartis Investigative Site, Timișoara

300480

Novartis Investigative Site, Tianjin

310009

Novartis Investigative Site, Zhenjiang

310016

Novartis Investigative Site, Hangzhou

344037

Novartis Investigative Site, Rostov-on-Don

390011

Novartis Investigative Site, Ryazan

400016

Novartis Investigative Site, Chongqing

400124

Novartis Investigative Site, Cluj-Napoca

407219

Novartis Investigative Site, Taichung

420029

Novartis Investigative Site, Kazan'

430022

Novartis Investigative Site, Wuhan

450008

Novartis Investigative Site, Zhengzhou

450054

Novartis Investigative Site, Ufa

454087

Novartis Investigative Site, Chelyabinsk

460021

Novartis Investigative Site, Orenburg

510000

Novartis Investigative Site, Guangzhou

533615

Novartis Investigative Site, Dublin

603137

Novartis Investigative Site, Nizhny Novgorod

610041

Novartis Investigative Site, Chengdu

625041

Novartis Investigative Site, Tyumen

630000

Novartis Investigative Site, Novosibirsk

644013

Novartis Investigative Site, Omsk

660022

Novartis Investigative Site, Krasnoyarsk

941105

UCLA Pasadena HC Hemato Onco, Pasadena

35294-0006

University of Alabama at Birmingham-Kirklin Clinic, Birmingham

94304-1509

Stanford University Medical Center, Palo Alto

90509-2910

Lundquist Inst BioMed at Harbor, Torrance

06052

Hospital of Central Connecticut, New Britain

06520

Yale University School Of Medicine, New Haven

06856

Norwalk Hospital, Norwalk

06360

Eastern Connecticut Hematology and Oncology Associates, Norwich

67214-3728

Cancer Center of Kansas, Wichita

02114

Massachusetts General Hospital, Boston

07039

Saint Barnabas Medical Center, Livingston

53792 6164

University of Wisconsin Paul P Carbone Comp Cancer Center, Madison

S2000

Novartis Investigative Site, Rosario

S200KZE

Novartis Investigative Site, Rosario

T4000IAK

Novartis Investigative Site, San Miguel Tucuman

C1419AHN

Novartis Investigative Site, CABA

X5004FHP

Novartis Investigative Site, Córdoba

86015-520

Novartis Investigative Site, Londrina

98700-000

Novartis Investigative Site, Ijuí

90035-903

Novartis Investigative Site, Porto Alegre

90050-170

Novartis Investigative Site, Porto Alegre

90560-030

Novartis Investigative Site, Porto Alegre

90610-000

Novartis Investigative Site, Porto Alegre

90880-480

Novartis Investigative Site, Porto Alegre

14784 400

Novartis Investigative Site, Barretos

09060-650

Novartis Investigative Site, Santo André

01317 000

Novartis Investigative Site, São Paulo

04014-002

Novartis Investigative Site, São Paulo

95070-560

Novartis Investigative Site, Caxias do Sul

99010-080

Novartis Investigative Site, Passo Fundo

13419-155

Novartis Investigative Site, Piracicaba

50040-000

Novartis Investigative Site, Recife

20560-120

Novartis Investigative Site, Rio de Janeiro

41810 570

Novartis Investigative Site, Salvador

01255-000

Novartis Investigative Site, São Paulo

T2N 4N2

Novartis Investigative Site, Calgary

T6G 1Z2

Novartis Investigative Site, Edmonton

V1Y 5L3

Novartis Investigative Site, Kelowna

V7L 2L7

Novartis Investigative Site, North Vancouver

V3V 1Z2

Novartis Investigative Site, Surrey

V5Z 4E6

Novartis Investigative Site, Vancouver

B3H 2Y9

Novartis Investigative Site, Halifax

P3E 5J1

Novartis Investigative Site, Greater Sudbury

N2G 1G3

Novartis Investigative Site, Kitchener

N6A 5W9

Novartis Investigative Site, London

J7Y 2P9

Novartis Investigative Site, Newmarket

L1G 2B9

Novartis Investigative Site, Oshawa

P6B 0A8

Novartis Investigative Site, Sault Ste. Marie

M4N 3M5

Novartis Investigative Site, Toronto

M5G 2M9

Novartis Investigative Site, Toronto

N8W 2X3

Novartis Investigative Site, Windsor

J1H 5N4

Novartis Investigative Site, Fleurimont

J4V 2H1

Novartis Investigative Site, Greenfield Park

H2W 1T8

Novartis Investigative Site, Montreal

H3T 1E2

Novartis Investigative Site, Montreal

H4A 3J1

Novartis Investigative Site, Montreal

G1S 4L8

Novartis Investigative Site, Québec

J7Z 5T3

Novartis Investigative Site, Saint-Jérôme

050011

Novartis Investigative Site, Shijiazhuang

06189

Novartis Investigative Site, Nice

F 67085

Novartis Investigative Site, Strasbourg

03048

Novartis Investigative Site, Cottbus

01307

Novartis Investigative Site, Dresden

04924

Novartis Investigative Site, Bad Liebenwerda

H-1032

Novartis Investigative Site, Budapest

H-1083

Novartis Investigative Site, Budapest

H-1145

Novartis Investigative Site, Budapest

H-9700

Novartis Investigative Site, Szombathely

H 2800

Novartis Investigative Site, Tatabánya

T12 DC4A

Novartis Investigative Site, Wilton

V94 F858

Novartis Investigative Site, County Limerick

D03 VX82

Novartis Investigative Site, Dublin

DO4

Novartis Investigative Site, Dublin

DUBLIN 9

Novartis Investigative Site, Dublin

00128

Novartis Investigative Site, Roma

02 781

Novartis Investigative Site, Warsaw

15-027

Novartis Investigative Site, Bialystok

81 519

Novartis Investigative Site, Gdynia

44 101

Novartis Investigative Site, Gliwice

86 300

Novartis Investigative Site, Grudziądz

90-338

Novartis Investigative Site, Lodz

20 090

Novartis Investigative Site, Lublin

45 054

Novartis Investigative Site, Opole

07-410

Novartis Investigative Site, Ostrołęka

05 400

Novartis Investigative Site, Otwock

05-135

Novartis Investigative Site, Wieliszew

02-781

Novartis Investigative Site, Wroclaw

011171

Novartis Investigative Site, Bucharest

06591

Novartis Investigative Site, Seoul

405 760

Novartis Investigative Site, Incheon

463-712

Novartis Investigative Site, Seongnam

02841

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

158-710

Novartis Investigative Site, Seoul

03203

Novartis Investigative Site, Elche

01009

Novartis Investigative Site, Vitoria-Gasteiz

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08242

Novartis Investigative Site, Manresa

08208

Novartis Investigative Site, Sabadell

08916

Novartis Investigative Site, Badalona

08035

Novartis Investigative Site, Barcelona

06080

Novartis Investigative Site, Badajoz

03550

Novartis Investigative Site, Alicante

08036

Novartis Investigative Site, Barcelona

09006

Novartis Investigative Site, Burgos

TR1 3LJ

Novartis Investigative Site, Truro

SM2 5PT

Novartis Investigative Site, Sutton

CF14 2TL

Novartis Investigative Site, Cardiff

NW1 2BU

Novartis Investigative Site, London

SE1 9RT

Novartis Investigative Site, London

SW3 6JJ

Novartis Investigative Site, London

NG5 1PB

Novartis Investigative Site, Nottingham

OX3 7LE

Novartis Investigative Site, Oxford

PR2 9HT

Novartis Investigative Site, Preston

ST4 6QG

Novartis Investigative Site, Stoke-on-Trent

Sponsors
All Listed Sponsors
collaborator

Translational Research in Oncology

OTHER

lead

Novartis Pharmaceuticals

INDUSTRY