Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,400

Participants

Timeline

Start Date

February 28, 2024

Primary Completion Date

September 7, 2029

Study Completion Date

September 20, 2030

Conditions
Early Breast Cancer
Interventions
DRUG

Ribociclib

Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest

DRUG

Letrozole

Letrozole 2.5 mg orally once daily continuously

DRUG

Ansastrozole

Anastrozole 1 mg orally once daily continuously.

DRUG

Goserelin

Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used

DRUG

Leuprolide

Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used

DRUG

Exemestane

Exemestane 25 mg once daily continuously

Trial Locations (141)

114

RECRUITING

Novartis Investigative Site, Taipei

810

RECRUITING

Novartis Investigative Site, Tiwi

970

RECRUITING

Novartis Investigative Site, Hualien City

2290

RECRUITING

Novartis Investigative Site, Gateshead

3002

RECRUITING

Novartis Investigative Site, East Melbourne

3168

RECRUITING

Novartis Investigative Site, Clayton

6800

RECRUITING

Novartis Investigative Site, Ankara

10002

RECRUITING

Novartis Investigative Site, Taipei

10029

RECRUITING

Mount Sinai School of Medicine, New York

10408

RECRUITING

Novartis Investigative Site, Gyeonggi-do

10967

RECRUITING

Novartis Investigative Site, Berlin

11042

RECRUITING

Clinical Research Alliance, Lake Success

13125

RECRUITING

Novartis Investigative Site, Berlin

13620

RECRUITING

Novartis Investigative Site, Bundang Gu

19026

RECRUITING

Consultants In Med Onco And Hema, Drexel Hill

20010

RECRUITING

Washington Hospital Center, Washington D.C.

20070

RECRUITING

Novartis Investigative Site, Denizli

20246

RECRUITING

Novartis Investigative Site, Hamburg

20904

RECRUITING

Maryland Oncology Hematology P A, Silver Spring

21202

RECRUITING

Mercy Medical Center, Baltimore

21280

RECRUITING

Novartis Investigative Site, Diyarbakır

23502

RECRUITING

Virginia Oncology Associates, Norfolk

23563

RECRUITING

Novartis Investigative Site, Lübeck

24105

RECRUITING

Novartis Investigative Site, Kiel

31134

RECRUITING

Novartis Investigative Site, Hildesheim

31405

RECRUITING

Summit Cancer Care PC, Savannah

33308

RECRUITING

Holy Cross Health, Fort Lauderdale

33604

RECRUITING

Novartis Investigative Site, Bielefeld

34098

RECRUITING

Novartis Investigative Site, Istanbul

34457

RECRUITING

Novartis Investigative Site, Istanbul

34474

RECRUITING

Ocala Research Institute, Inc, Ocala

34662

RECRUITING

Novartis Investigative Site, Istanbul

34722

RECRUITING

Novartis Investigative Site, Istanbul

35575

RECRUITING

Novartis Investigative Site, Izmir

37203

RECRUITING

Sarah Cannon Research Institute, Nashville

39202

RECRUITING

Jackson Oncology Associates, Jackson

40225

RECRUITING

Novartis Investigative Site, Düsseldorf

41061

RECRUITING

Novartis Investigative Site, Mönchengladbach

42080

RECRUITING

Novartis Investigative Site, Konya

42551

RECRUITING

Novartis Investigative Site, Velbert

45136

RECRUITING

Novartis Investigative Site, Essen

45147

RECRUITING

Novartis Investigative Site, Essen

46236

RECRUITING

Novartis Investigative Site, Bottrop

46260

RECRUITING

Investigative Clinical R of Indiana, Indianapolis

51465

RECRUITING

Novartis Investigative Site, Bergisch Gladbach

54290

RECRUITING

Novartis Investigative Site, Sakarya

55131

RECRUITING

Novartis Investigative Site, Mainz

55200

RECRUITING

Novartis Investigative Site, Samsun

55404

RECRUITING

Minnesota Oncology Hematology P A, Minneapolis

59101

RECRUITING

Intermountain Healthcare, Billings

60415

RECRUITING

Affiliated Oncologists IL, Chicago

60521

RECRUITING

Hope And Healing Care, Hinsdale

63110

RECRUITING

WA Uni School Of Med, St Louis

63225

RECRUITING

Novartis Investigative Site, Langen

66205

RECRUITING

University of Kansas Cancer Center, Westwood

68154

RECRUITING

Nebraska Cancer Specialists, Omaha

71004

RECRUITING

Novartis Investigative Site, Tainan City

71032

RECRUITING

Novartis Investigative Site, Böblingen

71103

RECRUITING

Willis-Knighton Cancer Center, Shreveport

72205

RECRUITING

CARTI Cancer Center, Little Rock

75075

RECRUITING

Texas Oncology P A Plano East, Plano

75702

RECRUITING

Texas Oncology PA Tyler, Tyler

79106

RECRUITING

Novartis Investigative Site, Freiburg im Breisgau

79902

RECRUITING

El Paso Texas Oncology, El Paso

80218

RECRUITING

Rocky Mountain Cancer Centers, Denver

80637

RECRUITING

Novartis Investigative Site, München

80756

RECRUITING

Novartis Investigative Site, Kaohsiung City

81377

RECRUITING

Novartis Investigative Site, Munich

86150

RECRUITING

Novartis Investigative Site, Augsburg

86179

RECRUITING

Novartis Investigative Site, Augsburg

88214

RECRUITING

Novartis Investigative Site, Ravensburg

89502

RECRUITING

Renown Regional Medical Center, Reno

91054

RECRUITING

Novartis Investigative Site, Erlangen

92637

RECRUITING

Novartis Investigative Site, Weiden

92868

RECRUITING

UC Irvine Medical Center, Orange

93053

RECRUITING

Novartis Investigative Site, Regensburg

94040

RECRUITING

Palo Alto Medical Foundation, Mountain View

97210

RECRUITING

Northwest Cancer Specialists, Portland

97301

RECRUITING

Oregon Oncology Specialists Salem, Salem

98405

RECRUITING

Northwest Medical Specialties, Tacoma

98503

RECRUITING

Providence Regional Cancer System, Lacey

99508

RECRUITING

Alaska Oncology and Hematology LLC, Anchorage

100730

RECRUITING

Novartis Investigative Site, Beijing

110029

RECRUITING

Novartis Investigative Site, New Delhi

130021

RECRUITING

Novartis Investigative Site, Changchun

200032

RECRUITING

Novartis Investigative Site, Shanghai

210029

RECRUITING

Novartis Investigative Site, Nanjing

250021

RECRUITING

Novartis Investigative Site, Jinan

310006

RECRUITING

Novartis Investigative Site, Hangzhou

310022

RECRUITING

Novartis Investigative Site, Hangzhou

330009

RECRUITING

Novartis Investigative Site, Nanchang

380054

RECRUITING

Novartis Investigative Site, Ahmedabad

422001

RECRUITING

Novartis Investigative Site, Nashik

450052

RECRUITING

Novartis Investigative Site, Zhengzhou

510060

RECRUITING

Novartis Investigative Site, Guangzhou

610041

RECRUITING

Novartis Investigative Site, Chengdu

610072

RECRUITING

Novartis Investigative Site, Chengdu

830000

RECRUITING

Novartis Investigative Site, Ürümqi

999077

RECRUITING

Novartis Investigative Site, Hong Kong

RECRUITING

Novartis Investigative Site, Pokfulam

RECRUITING

Novartis Investigative Site, Tuenmen

999999

RECRUITING

Novartis Investigative Site, Kowloon

4941492

RECRUITING

Novartis Investigative Site, Petah Tikva

5265601

RECRUITING

Novartis Investigative Site, Ramat Gan

6423906

RECRUITING

Novartis Investigative Site, Tel Aviv

8457108

RECRUITING

Novartis Investigative Site, Beersheba

67214-3728

RECRUITING

Cancer Center of Kansas, Wichita

07450

RECRUITING

The Valley Hospital, Ridgewood

97401-8122

RECRUITING

Oncology Associates of Oregon PC, Eugene

02903

RECRUITING

Rhode Island Hospital, Providence

B3H 2Y9

RECRUITING

Novartis Investigative Site, Halifax

K1H 8L6

RECRUITING

Novartis Investigative Site, Ottawa

H2X 0A9

RECRUITING

Novartis Investigative Site, Montreal

H3T 1E2

RECRUITING

Novartis Investigative Site, Montreal

H4A 3J1

RECRUITING

Novartis Investigative Site, Montreal

G1S 4L8

RECRUITING

Novartis Investigative Site, Québec

01307

RECRUITING

Novartis Investigative Site, Dresden

06847

RECRUITING

Novartis Investigative Site, Dessau

04277

RECRUITING

Novartis Investigative Site, Leipzig

500 034

RECRUITING

Novartis Investigative Site, Hyderabad

600 035

RECRUITING

Novartis Investigative Site, Chennai

400 012

RECRUITING

Novartis Investigative Site, Mumbai

4100-180

RECRUITING

Novartis Investigative Site, Porto

4200 319

RECRUITING

Novartis Investigative Site, Porto

4200-072

RECRUITING

Novartis Investigative Site, Porto

06591

RECRUITING

Novartis Investigative Site, Seoul

405 760

RECRUITING

Novartis Investigative Site, Incheon

463-712

RECRUITING

Novartis Investigative Site, Seongnam Gyeonggi

02841

RECRUITING

Novartis Investigative Site, Seoul

03080

RECRUITING

Novartis Investigative Site, Seoul

03722

RECRUITING

Novartis Investigative Site, Seoul

05505

RECRUITING

Novartis Investigative Site, Seoul

06273

RECRUITING

Novartis Investigative Site, Seoul

06351

RECRUITING

Novartis Investigative Site, Seoul

158-710

RECRUITING

Novartis Investigative Site, Seoul

07070

RECRUITING

Novartis Investigative Site, Antalya

06230

RECRUITING

Novartis Investigative Site, Ankara

06200

RECRUITING

Novartis Investigative Site, Ankara

06500

RECRUITING

Novartis Investigative Site, Ankara

06520

RECRUITING

Novartis Investigative Site, Ankara

06010

RECRUITING

Novartis Investigative Site, Kecioren Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY