A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

PHASE2CompletedINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

February 26, 2013

Primary Completion Date

July 2, 2018

Study Completion Date

July 30, 2018

Conditions
Breast Cancer
Interventions
DRUG

Capecitabine

Capecitabine, tablets for oral use, 1250 mg/m² twice daily for 2 weeks followed by one week rest (3-week-cycle) (locally supplied)

DRUG

Exemestane

Exemestane, tablets for oral use, 25 mg per day in (locally supplied)

DRUG

Everolimus

Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied)

Trial Locations (83)

11

Novartis Investigative Site, Jesus Maria

34

Novartis Investigative Site, Surquillo

41

Novartis Investigative Site, San Borja

470

Novartis Investigative Site, Hazmiyeh

652

Novartis Investigative Site, Saida

1145

Novartis Investigative Site, Budapest

2031

Novartis Investigative Site, Randwick

2076

Novartis Investigative Site, Wahroonga

2800

Novartis Investigative Site, Tatabánya

3050

Novartis Investigative Site, Parkville

3144

Novartis Investigative Site, Malvern

4000

Novartis Investigative Site, Liège

Novartis Investigative Site, Roskilde

4032

Novartis Investigative Site, Debrecen

7100

Novartis Investigative Site, Vejle

8500

Novartis Investigative Site, Rio Negro

15000

Novartis Investigative Site, Lopburi

28033

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

33901

Florida Cancer Specialists Dept of Oncology (2), Fort Myers

Florida Cancer Specialists FL Cancer Specialists, Fort Myers

34303

Novartis Investigative Site, Istanbul

35340

Novartis Investigative Site, Izmir

37203

Sarah Cannon Research Institute SC (2), Nashville

37404

Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology, Chattanooga

38138

The Jones Clinic SC, Germantown

40002

Novartis Investigative Site, Muang

41013

Novartis Investigative Site, Seville

45242

Oncology Hematology Care Inc Oncology Hematology Care 2, Cincinnati

59100

Novartis Investigative Site, Kuala Lumpur

59901

Glacier View Research Institute - Cancer SC, Kalispell

74136

Oklahoma Cancer Specialists and Research Institute Oklahoma Cancer Specialists, Tulsa

76104

The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD, Fort Worth

88586

Novartis Investigative Site, Kota Kinabalu

90095

University of California at Los Angeles Mattel Children's Hospital, Los Angeles

90110

Novartis Investigative Site, Songkhla

92123

Sharp Memorial Hospital SharpClinicalOncologyResearch, San Diego

98405

Northwest Medical Specialties Dept of Onc, Tacoma

115478

Novartis Investigative Site, Moscow

163045

Novartis Investigative Site, Arkhangelsk

166830

Novartis Investigative Site, El Achrafiyé

197758

Novartis Investigative Site, Saint Petersburg

411013

Novartis Investigative Site, Pune

01805

Lahey Clinic Dept of Lahey Clinic (2), Burlington

02462

New England Hematology/ Oncology Associates, P.C. SC, Newton

07207

Trinitas Comprehensive Cancer Center SC, Elizabeth

07601

Hackensack University Medical Center Dept of Oncology, Hackensack

07101

Rutgers-New Jersey Medical School SC, Newark

27920-6969

University of Tennessee SC, Knoxville

22908-0334

University of Virginia Health Systems SC-4, Charlottesville

C1025ABI

Novartis Investigative Site, CABA

Unknown

Novartis Investigative Site, Posadas

Novartis Investigative Site, Limerick

Novartis Investigative Site, Galway

Novartis Investigative Site, Beirut

Novartis Investigative Site, Arequipa

S2000KZE

Novartis Investigative Site, Rosario

X5016KEH

Novartis Investigative Site, Córdoba

41253-190

Novartis Investigative Site, Salvador

59075 740

Novartis Investigative Site, Natal

99010-260

Novartis Investigative Site, Passo Fundo

90610-000

Novartis Investigative Site, Porto Alegre

01317-002

Novartis Investigative Site, São Paulo

8000 C

Novartis Investigative Site, Aarhus

DK-2100

Novartis Investigative Site, Copenhagen

DK-4700

Novartis Investigative Site, Næstved

DK 5000

Novartis Investigative Site, Odense C

500 034

Novartis Investigative Site, Hyderabad

700 053

Novartis Investigative Site, Kolkata

400 012

Novartis Investigative Site, Mumbai

D04 T6F

Novartis Investigative Site, Dublin

1107 2020

Novartis Investigative Site, Beirut

08035

Novartis Investigative Site, Barcelona

SE-631 88

Novartis Investigative Site, Eskilstuna

551 85

Novartis Investigative Site, Jönköping

SE-171 76

Novartis Investigative Site, Stockholm

SE-751 85

Novartis Investigative Site, Uppsala

SE-351 85

Novartis Investigative Site, Vaxjo

721 89

Novartis Investigative Site, Västerås

01330

Novartis Investigative Site, Adana

G75 8RG

Novartis Investigative Site, East Kilbride

TS4 3BW

Novartis Investigative Site, Middlesbrough

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY