Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Dovitinib

Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule

DRUG

Fulvestrant

Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.

DRUG

Dovitinib Placebo

Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule

Trial Locations (67)

34

Novartis Investigative Site, Surquillo

407

Novartis Investigative Site, Taichung

1090

Novartis Investigative Site, Vienna

1134

Novartis Investigative Site, Budapest

1145

Novartis Investigative Site, Budapest

2193

Novartis Investigative Site, Parktown

2610

Novartis Investigative Site, Wilrijk

3000

Novartis Investigative Site, Leuven

4032

Novartis Investigative Site, Debrecen

5020

Novartis Investigative Site, Salzburg

6045

Novartis Investigative Site, Port Elizabeth

7500

Novartis Investigative Site, Cape Town

8500

Novartis Investigative Site, Rio Negro

10048

Novartis Investigative Site, Taipei

11042

ProHealth Care, Lake Success

12180

New York Oncology Hematology, P.C. Dept. of New York Oncology. PC, Troy

22031

Virginia Cancer Specialists, PC Dept.ofFairfax SC, Fairfax

23100

Novartis Investigative Site, Sondrio

25030

Novartis Investigative Site, Besançon

27710

Duke University Medical Center Duke (SC), Durham

28007

Novartis Investigative Site, Madrid

29605

Cancer Centers of the Carolinas Dept. of CC of the Carolinas, Greenville

33076

Novartis Investigative Site, Bordeaux

33612

H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC, Tampa

43100

Novartis Investigative Site, Parma

44805

Novartis Investigative Site, Saint-Herblain Cédex

45071

Novartis Investigative Site, Toledo

46010

Novartis Investigative Site, Valencia

46526

Indiana University Health Goshen Center for Cancer SC, Goshen

59020

Novartis Investigative Site, Lille

62100

Novartis Investigative Site, Macerata

68114

Nebraska Methodist Hospital Estabrook Cancer Center, Omaha

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

74203

Novartis Investigative Site, Thonon-les-Bains

78229

Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2), San Antonio

83301

Novartis Investigative Site, Niaosong Township

85224

Ironwood Cancer and Research Centers SC, Chandler

90048

Cedars Sinai Medical Center Samuel Oschin Cancer Center, Los Angeles

94805

Novartis Investigative Site, Villejuif

98801

Wenatchee Valley Medical Center Wenatchee Valley, Wenatchee

99208

Medical Oncology Associates, PS, Spokane

197758

Novartis Investigative Site, Saint Petersburg

390011

Novartis Investigative Site, Ryazan

91010-3000

City of Hope National Medical Center COH 3, Duarte

92093-0658

University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1, La Jolla

60068-0736

Oncology Specialists, SC Lutheran General Advanced Care, Park Ridge

07039

Saint Barnabas Medical Center CancerCenter of Saint Barnabas, Livingston

C1050AAK

Novartis Investigative Site, Buenos Aires

X5006IKK

Novartis Investigative Site, Córdoba

T4000IAK

Novartis Investigative Site, San Miguel de Tucumán

40170-110

Novartis Investigative Site, Salvador

86015-520

Novartis Investigative Site, Londrina

90610-000

Novartis Investigative Site, Porto Alegre

15090-000

Novartis Investigative Site, São José do Rio Preto

01317-002

Novartis Investigative Site, São Paulo

H-9023

Novartis Investigative Site, Győr

H-1083

Novartis Investigative Site, Budapest

H-6720

Novartis Investigative Site, Szeged

H-5000

Novartis Investigative Site, Szolnok

6229 HX

Novartis Investigative Site, Maastricht

3075 EA

Novartis Investigative Site, Rotterdam

60-569

Novartis Investigative Site, Poznan

35-021

Novartis Investigative Site, Rzeszów

02-781

Novartis Investigative Site, Warsaw

03-291

Novartis Investigative Site, Warsaw

04-125

Novartis Investigative Site, Warsaw

08035

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY