Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

376

Participants

Timeline

Start Date

June 11, 2019

Primary Completion Date

June 11, 2021

Study Completion Date

August 30, 2024

Conditions
Breast Cancer
Interventions
DRUG

Ribociclib

Ribociclib (at a dosage of 400 mg or 600 mg) QD orally taken on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (days 22 to 28). Ribociclib was supplied as 200 mg tablets as individual patient supply packaged bottles.

DRUG

Anastrozole

Anastrozole 1 mg tablets for oral use QD continuously

DRUG

Letrozole

Letrozole 2.5 mg tablets for oral use QD continuously

DRUG

Goserelin

Goserelin 3.6 mg subcutaneously once every 4 weeks (pre-menopausal women only)

Trial Locations (89)

27

Novartis Investigative Site, San Isidro

32

Novartis Investigative Site, San Miguel

41

Novartis Investigative Site, San Borja

1090

Novartis Investigative Site, Vienna

1303

Novartis Investigative Site, Sofia

1756

Novartis Investigative Site, Sofia

2193

Novartis Investigative Site, Parktown

2196

Novartis Investigative Site, Johannesburg

2650

Novartis Investigative Site, Edegem

4004

Novartis Investigative Site, Plovdiv

4010

Novartis Investigative Site, Linz

4032

Novartis Investigative Site, Debrecen

5000

Novartis Investigative Site, Namur

5020

Novartis Investigative Site, Salzburg

6020

Novartis Investigative Site, Innsbruck

7500

Novartis Investigative Site, Cape Town

10029

Mount Sinai School Of Medicine, New York

10467

Montefiore Medical Center, The Bronx

10700

Novartis Investigative Site, Bangkok

11941

Novartis Investigative Site, Amman

12208

New York Oncology Hematology, Albany

13011

Novartis Investigative Site, Trujillo

13273

Novartis Investigative Site, Marseille

13581

Novartis Investigative Site, Berlin

14021

Novartis Investigative Site, Caen

25030

Novartis Investigative Site, Besançon

32804

Florida Retina Institute, Orlando

34298

Novartis Investigative Site, Montpellier

36608

Southern Cancer Center PC, Mobile

44805

Novartis Investigative Site, Saint-Herblain

45136

Novartis Investigative Site, Essen

50200

Novartis Investigative Site, Chiang Mai

53111

Novartis Investigative Site, Bonn

59300

Novartis Investigative Site, Valenciennes

63011

Novartis Investigative Site, Clermont-Ferrand

63225

Novartis Investigative Site, Langen

68154

Nebraska Cancer Specialists, Omaha

68506

Nebraska Hematology Oncology P C, Lincoln

69373

Novartis Investigative Site, Lyon 08

72076

Novartis Investigative Site, Tübingen

77090

Millennium Research Clin Develop, Houston

78503

Texas Oncology, McAllen

80501

Rocky Mountain Cancer Centers, Longmont

86150

Novartis Investigative Site, Augsburg

89052

Comprehensive Cancer Cntr Of Nevada, Henderson

92637

Novartis Investigative Site, Weiden

94904

Marin Cancer Care, Greenbrae

95008

Novartis Investigative Site, San José

98405

Northwest Medical Specialties, Tacoma

110131

Novartis Investigative Site, Bogotá

110221

Novartis Investigative Site, Bogotá

111123

Novartis Investigative Site, Moscow

115478

Novartis Investigative Site, Moscow

163045

Novartis Investigative Site, Arkhangelsk

197758

Novartis Investigative Site, Saint Petersburg

230002

Novartis Investigative Site, Montería

441108

Novartis Investigative Site, Nagpur

492001

Novartis Investigative Site, Raipur

730006

Novartis Investigative Site, Ibagué

751007

Novartis Investigative Site, Bhubaneshwar

2674514

Novartis Investigative Site, Loures

5602310

Novartis Investigative Site, Valledupar

21237-3998

Weinberg Cancer Institute at FSH, Baltimore

J5402DIL

Novartis Investigative Site, San Juan

59075 740

Novartis Investigative Site, Natal

88034 000

Novartis Investigative Site, Florianópolis

01317 000

Novartis Investigative Site, São Paulo

04014-002

Novartis Investigative Site, São Paulo

74605-070

Novartis Investigative Site, Goiânia

15090 000

Novartis Investigative Site, São José do Rio Preto

N1R 3G2

Novartis Investigative Site, Cambridge

656 53

Novartis Investigative Site, Brno

150 06

Novartis Investigative Site, Prague

00029

Novartis Investigative Site, Helsinki

FIN-33521

Novartis Investigative Site, Tampere

F 67085

Novartis Investigative Site, Strasbourg

01127

Novartis Investigative Site, Dresden

01307

Novartis Investigative Site, Dresden

H 1122

Novartis Investigative Site, Budapest

H-5000

Novartis Investigative Site, Szolnok

110 085

Novartis Investigative Site, Delhii

400 012

Novartis Investigative Site, Mumbai

LT 50161

Novartis Investigative Site, Kaunas

LT-08660

Novartis Investigative Site, Vilnius

1400-038

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

112 19

Novartis Investigative Site, Stockholm

SE-118 83

Novartis Investigative Site, Stockholm

751 85

Novartis Investigative Site, Uppsala

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY