Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

PHASE3CompletedINTERVENTIONAL
Enrollment

724

Participants

Timeline

Start Date

June 3, 2009

Primary Completion Date

December 4, 2014

Study Completion Date

December 4, 2014

Conditions
Breast Cancer
Interventions
DRUG

Everolimus

Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

DRUG

Exemestane

Exemestane 25 mg orally daily.

DRUG

Everolimus Placebo

Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Trial Locations (200)

1000

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Brussels

2610

Novartis Investigative Site, Wilrijk

3000

Novartis Investigative Site, Leuven

3002

Novartis Investigative Site, Parkville

3050

Novartis Investigative Site, Parkville

4000

Novartis Investigative Site, Liège

4020

Novartis Investigative Site, Redcliffe

4560

Novartis Investigative Site, Nambour

5020

Novartis Investigative Site, Salzburg

5042

Novartis Investigative Site, Bedford Park

6008

Novartis Investigative Site, Subiaco

8001

Novartis Investigative Site, Christchurch

9100

Novartis Investigative Site, Sint-Niklaas

10003

Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2), New York

10021

Weill Cornell Medical College Weill Cornell Med. Ctr., New York

10098

Novartis Investigative Site, Berlin

10126

Novartis Investigative Site, Torino

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

10960

Hematology Oncology Association of Rockland, Nyack

11042

Clinical Research Alliance Dept.ofArenaOncologyAssoc(2), Lake Success

ProHealth Care, Lake Success

13008

Novartis Investigative Site, Marseille

14044

Novartis Investigative Site, Prague

15006

Novartis Investigative Site, A Coruña

15706

Novartis Investigative Site, Santiago de Compostela

16132

Novartis Investigative Site, Genova

20190

Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA, Reston

20910

Holy Cross Hospital Holy Cross, Silver Spring

21047

Novartis Investigative Site, Saronno

21100

Novartis Investigative Site, Varese

21202

Mercy Medical Center Medical Oncology & Hematology, Baltimore

21237

Maryland Hematology/Oncology Associates, P.A., Baltimore

21401

Anne Arundel Health System Research Institute Wayson Pavilion, Annapolis

21701

Frederick Memorial Hospital Dept. of FMH-IRB, Frederick

25198

Novartis Investigative Site, Lleida

27889

Marion L. Shepard Cancer Center, Washington

28033

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

29425

Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr, Charleston

30033

Georgia Cancer Specialists. Drug Ship, Decatur

32806

MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2), Orlando

33021

Memorial Hospital Memorial Cancer Institute, Hollywood

33248

Comprehensive Cancer Center - Boca Raton Deerfield Beach, Boca Raton

33328

Florida Cancer Research Institute, Davie

33401

Palm Beach Cancer Institute, West Palm Beach

33542

Florida Medical Clinic PA Dept.ofFloridaMedicalClinic, Zephyrhills

33901

Florida Cancer Specialists DeptofFloridaCancerSpecialists, Fort Myers

34662

Novartis Investigative Site, Altunizade

35040

Novartis Investigative Site, Izmir

37203

Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5), Nashville

40202

University of Louisville / James Graham Brown Cancer Center SC, Louisville

40225

Novartis Investigative Site, Düsseldorf

41017

Novartis Investigative Site, Seville

44600

Novartis Investigative Site, Saint-Nazaire

44805

Novartis Investigative Site, Saint-Herblain Cédex

46260

Hematology Oncology of Indiana, Indianapolis

47905

Horizon Oncology Center, Lafayette

48149

Novartis Investigative Site, Münster

50011

Novartis Investigative Site, Antella - Bagno A Ripoli

50200

Novartis Investigative Site, Chiang Mai

53792

University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2), Madison

54290

Novartis Investigative Site, Trier

55435

Fairview Southdale Medical Oncology Clinic, Edina

58128

Novartis Investigative Site, Hwasun-gun

60389

Novartis Investigative Site, Frankfurt

60612

Rush University Medical Center Study Coordinator, Chicago

62100

Novartis Investigative Site, Macerata

63141

St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast, St Louis

68165

Novartis Investigative Site, Mannheim

68510

Southeast Nebraska Oncology Cancer Center, Lincoln

69373

Novartis Investigative Site, Lyon

70006

Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2, Metairie

70808

Hematology Oncology Clinic Hematology Oncology Clinic (2), Baton Rouge

72000

Novartis Investigative Site, Le Mans

72100

Novartis Investigative Site, Brindisi

72703

Highlands Oncology Group DeptofHighlandsOncologyGrp(2), Fayetteville

73505

Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma, Lawton

74136

Cancer Care Associates SC, Tulsa

75010

Novartis Investigative Site, Paris

75080

Hope Oncology HOPE Richardson, Richardson

76000

Novartis Investigative Site, Rouen

76038

Novartis Investigative Site, Rouen

76104

The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2), Fort Worth

80637

Novartis Investigative Site, München

81377

Novartis Investigative Site, München

84106

Utah Cancer Specialists Dept.of Utah Cancer Spec. (2), Salt Lake City

84112

University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2), Salt Lake City

84604

Central Utah Clinic CRAD001Y2301, Provo

85224

Ironwood Cancer and Research Centers, Chandler

85925

Novartis Investigative Site, La Roche-sur-Yon

87131

University of New Mexico Cancer Research Center Dept of UNM Cancer & Research, Albuquerque

90025

The Angeles Clinic and Research Institute, Los Angeles

90053

USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3, Los Angeles

90110

Novartis Investigative Site, Songkhla

90404

Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ, Santa Monica

92121

Scripps Clinic SC, La Jolla

92123

Sharp Memorial Hospital SharpClinicalOncologyResearch, San Diego

92807

Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C, Anaheim

93309

Comprehensive Blood and Cancer Center Dept. of CBCC (3), Bakersfield

93720

Cancer Care Associates Dept.ofCancerCareAssoc. (2), Fresno

94101

University of California San Francisco UCSF Medical Center, San Francisco

94503

St Joseph Heritage Healthcare Dept. of RRMG (4), Santa Rosa

95100

Novartis Investigative Site, Catania

95945

Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc, Grass Valley

60068-0736

Oncology Specialists, SC Dept.of Oncology Specialists, Park Ridge

67214-3728

Cancer Center of Kansas Dept.ofCancerCtr.ofKansas, Wichita

21237-3998

Weinberg Cancer Institute at Franklin Square Hospital, Baltimore

01805

Lahey Clinic Dept of Lahey Clinic (2), Burlington

08003

Regional Cancer Care Associates Dept. of the CCHD, Cherry Hill

07207

Trinitas Comprehensive Cancer Center Dept. of Trinitas, Elizabeth

17033-0850

Penn State University / Milton S. Hershey Medical Center Division of Oncology (2), Hershey

75390-8852

University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr., Dallas

77030-4009

University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2), Houston

84403-3105

Northern Utah Cancer Associates SC, Ogden

A-6020

Novartis Investigative Site, Innsbruck

A-4600

Novartis Investigative Site, Wels

A-4010

Novartis Investigative Site, Linz

A-1090

Novartis Investigative Site, Vienna

41825-010

Novartis Investigative Site, Salvador

38408-150

Novartis Investigative Site, Uberlândia

20230-130

Novartis Investigative Site, Rio de Janeiro

90560-030

Novartis Investigative Site, Porto Alegre

01246-000

Novartis Investigative Site, São Paulo

T2N 4N2

Novartis Investigative Site, Calgary

E1C 6Z8

Novartis Investigative Site, Moncton

B3H 2Y9

Novartis Investigative Site, Halifax

N1R 3G2

Novartis Investigative Site, Cambridge

N6A 4L6

Novartis Investigative Site, London

J7Y 2P9

Novartis Investigative Site, Newmarket

L2S 0A9

Novartis Investigative Site, St. Catharines

M4C 3E7

Novartis Investigative Site, Toronto

M4N 3M5

Novartis Investigative Site, Toronto

M9N 1N8

Novartis Investigative Site, Weston

J4V 2H1

Novartis Investigative Site, Greenfield Park

H2W 1S6

Novartis Investigative Site, Montreal

H2W 1T8

Novartis Investigative Site, Montreal

H4J 1C5

Novartis Investigative Site, Montreal

G1S 4L8

Novartis Investigative Site, Québec

J1H 5N4

Novartis Investigative Site, Sherbrooke

656 53

Novartis Investigative Site, Brno

775 20

Novartis Investigative Site, Olomouc

Unknown

Novartis Investigative Site, Menoufiya

Novartis Investigative Site, Alexandria

Novartis Investigative Site, Cairo

Novartis Investigative Site, Hong Kong SAR

H-1122

Novartis Investigative Site, Budapest

H-6720

Novartis Investigative Site, Szeged

H-5000

Novartis Investigative Site, Szolnok

06129

Novartis Investigative Site, Perugia

05100

Novartis Investigative Site, Terni

464-8681

Novartis Investigative Site, Nagoya

277-8577

Novartis Investigative Site, Kashiwa

791-0280

Novartis Investigative Site, Matsuyama

811-1395

Novartis Investigative Site, Fukuoka

802-0077

Novartis Investigative Site, Kitakyushu

371-8511

Novartis Investigative Site, Maebashi

060-8648

Novartis Investigative Site, Sapporo

892-0833

Novartis Investigative Site, Kagoshima

259-1193

Novartis Investigative Site, Isehara

860-8556

Novartis Investigative Site, Kumamoto

606-8507

Novartis Investigative Site, Kyoto

537-8511

Novartis Investigative Site, Osaka

540-0006

Novartis Investigative Site, Osaka

565-0871

Novartis Investigative Site, Suita

350-1298

Novartis Investigative Site, Hidaka

362-0806

Novartis Investigative Site, Kitaadachi-gun

113-8677

Novartis Investigative Site, Bunkyo-ku

104-0045

Novartis Investigative Site, Chuo-ku

104-8560

Novartis Investigative Site, Chuo-ku

135-8550

Novartis Investigative Site, Koto

5631 BM

Novartis Investigative Site, Eindhoven

1815 JD

Novartis Investigative Site, Alkmaar

1090 HM

Novartis Investigative Site, Amsterdam

3318AT

Novartis Investigative Site, Dordrecht

6162 BG

Novartis Investigative Site, Sittard-Geleen

2545 CH

Novartis Investigative Site, The Hague

NO-1478

Novartis Investigative Site, Lørenskog

31-108

Novartis Investigative Site, Krakow

35-021

Novartis Investigative Site, Rzeszów

04-125

Novartis Investigative Site, Warsaw

03722

Novartis Investigative Site, Seoul

01812

Novartis Investigative Site, Seoul

07198

Novartis Investigative Site, Mallorca

07120

Novartis Investigative Site, Palma de Mallorca

08035

Novartis Investigative Site, Barcelona

08221

Novartis Investigative Site, Terrassa

SE-118 83

Novartis Investigative Site, Stockholm

SE-171 76

Novartis Investigative Site, Stockholm

SE-751 85

Novartis Investigative Site, Uppsala

06100

Novartis Investigative Site, Ankara

CM1 7ET

Novartis Investigative Site, Broomfield

TR1 3LJ

Novartis Investigative Site, Truro

CF14 2TL

Novartis Investigative Site, Cardiff

NG5 1PB

Novartis Investigative Site, Nottingham

S10 2SJ

Novartis Investigative Site, Sheffield

SO16 6YD

Novartis Investigative Site, Southampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY