Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

569

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
HER2/Neu Over-expressing Locally Advanced Breast CancerMetastatic Breast Cancer
Interventions
DRUG

everolimus

Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

DRUG

Placebo

Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

DRUG

vinorelbine

intravenous vinorelbine (25 mg/m2 weekly)

DRUG

trastuzumab

intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Trial Locations (161)

1000

Novartis Investigative Site, Brussels

1062

Novartis Investigative Site, Budapest

1090

Novartis Investigative Site, Brussels

2065

Novartis Investigative Site, St Leonards

2217

Novartis Investigative Site, Kogarah

3165

Novartis Investigative Site, East Bentleigh

4000

Novartis Investigative Site, Liège

4032

Novartis Investigative Site, Debrecen

4101

Novartis Investigative Site, South Brisbane

4215

Novartis Investigative Site, Southport

5000

Novartis Investigative Site, Namur

7000

Novartis Investigative Site, Hobart

7600

Novartis Investigative Site, Mar del Plata

8500

Novartis Investigative Site, Rio Negro

9100

Novartis Investigative Site, Sint-Niklaas

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

11042

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

14004

Novartis Investigative Site, Córdoba

14195

Novartis Investigative Site, Berlin

15006

Novartis Investigative Site, A Coruña

15009

Novartis Investigative Site, A Coruña

15232

University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2), Pittsburgh

18547

Novartis Investigative Site, Athens

20132

Novartis Investigative Site, Milan

20133

Novartis Investigative Site, Milan

20157

Novartis Investigative Site, Milan

20249

Novartis Investigative Site, Hamburg

22015

Novartis Investigative Site, Saint-Brieuc Cédex

22031

Virginia Cancer Specialists Fairfax No.VA (2), Fairfax

23007

Novartis Investigative Site, Jaén

23100

Novartis Investigative Site, Sondrio

23502

Virginia Oncology Associates Dept. of VOA (2), Norfolk

24105

Novartis Investigative Site, Kiel

25030

Novartis Investigative Site, Besançon

27100

Novartis Investigative Site, Pavia

27710

Duke University Medical Center Dept. of DUMC (2), Durham

28007

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Majadahonda

30322

Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2), Atlanta

32429

Novartis Investigative Site, Minden

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

Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr, Boca Raton

33916

Florida Cancer Specialists DeptofFloridaCancerSpecialists, Fort Myers

34098

Novartis Investigative Site, Fatih / Istanbul

35040

Novartis Investigative Site, Izmir

37000

Novartis Investigative Site, León

37203

Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6), Nashville

38138

The Jones Clinic Dept .of The Jones Clinic (3), Germantown

38320

Novartis Investigative Site, San Cristóbal de La Laguna

39108

Novartis Investigative Site, Magdeburg

41014

Novartis Investigative Site, Seville

41260

Novartis Investigative Site, La Chaussée-Saint-Victor

42551

Novartis Investigative Site, Velbert

45657

Novartis Investigative Site, Recklinghausen

46009

Novartis Investigative Site, Valencia

49100

Novartis Investigative Site, Petah Tikva

50009

Novartis Investigative Site, Zaragoza

54301

Green Bay Oncology Green Bay Oncology, Green Bay

55131

Novartis Investigative Site, Mainz

55416

Park Nicollet Institute Dept. of Park Nicollet, Saint Louis Park

60201

North Shore University Health System NSU, Evanston

60590

Novartis Investigative Site, Frankfurt

63110

St. Louis University Cancer Center SLU Cancer Center, St Louis

64100

Novartis Investigative Site, Bayonne

66210

Kansas City Cancer Center KCCC- South (2), Overland Park

66421

Novartis Investigative Site, Homburg

68198

University of Nebraska Medical Center Unv Nebraska Med Ctr (2), Omaha

70839

Novartis Investigative Site, Gerlingen

75230

Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2), Dallas

75246

Texas Oncology Presbyterian Hospital (2), Dallas

Texas Oncology Texas Onc - Amarillo, Dallas

Texas Oncology Texas Oncology - Sammons, Dallas

75251

Texas Oncology Midtown, Dallas

75601

Longview Cancer Center Longview Cancer Center (2), Longview

75702

Tyler Cancer Center Dept.ofTylerCancerCtr. (2), Tyler

77030

Baylor College of Medicine Baylor, Houston

78229

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

78258

South Texas Oncology and Hematology, PA South Texas Oncology (2), San Antonio

80638

Novartis Investigative Site, München

83310

Novartis Investigative Site, Bratislava

83400

Novartis Investigative Site, Hyères

84106

Utah Cancer Specialists Utah Cancer (2), Salt Lake City

85724

University of Arizona / Cancer Center AZ Onc Assoc, Tucson

University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3), Tucson

85925

Novartis Investigative Site, La Roche-sur-Yon

89109

Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4), Las Vegas

89135

Nevada Cancer Institute Dept. of Nevada Cancer (3), Las Vegas

90110

Novartis Investigative Site, Songkhla

94805

Novartis Investigative Site, Villejuif

95125

Novartis Investigative Site, Catania

97210

Northwest Cancer Specialists Tutlatin, Portland

98104

Swedish Cancer Institute Swedish Cancer Institute, Seattle

100021

Novartis Investigative Site, Beijing

100039

Novartis Investigative Site, Beijing

169610

Novartis Investigative Site, Singapore

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

310022

Novartis Investigative Site, Hangzhou

510060

Novartis Investigative Site, Guangzhou

5266202

Novartis Investigative Site, Ramat Gan

6423906

Novartis Investigative Site, Tel Aviv

9112001

Novartis Investigative Site, Jerusalem

92093-0658

University of California San Diego - Moores Cancer Center La Jolla - UCSD Moores Cancer, La Jolla

Unknown

Rocky Mountain Cancer Centers RMCC, Greenwood Village

Novartis Investigative Site, Posadas

20007-2197

Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3), Washington D.C.

21117,

Maryland Oncology Hematology, Owning Mills

07901

Overlook Hospital - Carol G Simon Cancer Center Carol G Simon, Summit

75390-8852

University of Texas Southwestern Medical Center University of TX SW Med Ctr(2), Dallas

77030-4009

University of Texas/MD Anderson Cancer Center SC-5, Houston

C1019ABS

Novartis Investigative Site, C A B A

C1050AAK

Novartis Investigative Site, Caba

B1878DVB

Novartis Investigative Site, Quilmes

X5002AOQ

Novartis Investigative Site, Córdoba

S200KZE

Novartis Investigative Site, Rosario

T4000IAK

Novartis Investigative Site, San Miguel de Tucumán

741 01

Novartis Investigative Site, Nový Jičín

775 20

Novartis Investigative Site, Olomouc

150 00

Novartis Investigative Site, Prague

06189

Novartis Investigative Site, Nice

06120

Novartis Investigative Site, Halle

711 10

Novartis Investigative Site, Heraklion Crete

151 23

Novartis Investigative Site, Athens

265 04

Novartis Investigative Site, Patra - RIO

546 45

Novartis Investigative Site, Thessaloniki

564 03

Novartis Investigative Site, Thessaloniki

H-9023

Novartis Investigative Site, Győr

H-1122

Novartis Investigative Site, Budapest

464-8681

Novartis Investigative Site, Nagoya

277-8577

Novartis Investigative Site, Kashiwa

811-1395

Novartis Investigative Site, Fukuoka

371-8511

Novartis Investigative Site, Maebashi

003-0804

Novartis Investigative Site, Sapporo

241-8515

Novartis Investigative Site, Yokohama

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

113-8431

Novartis Investigative Site, Bunkyo-ku

135-8550

Novartis Investigative Site, Koto

04980

Novartis Investigative Site, Mexico City

20-090

Novartis Investigative Site, Lublin

02-781

Novartis Investigative Site, Warsaw

040 91

Novartis Investigative Site, Košice

08041

Novartis Investigative Site, Barcelona

08208

Novartis Investigative Site, Sabadell

08036

Novartis Investigative Site, Barcelona

06100

Novartis Investigative Site, Ankara

TR1 3LJ

Novartis Investigative Site, Truro

GU2 7XX

Novartis Investigative Site, Surrey

BH7 7DW

Novartis Investigative Site, Bournemouth

LS9 7TF

Novartis Investigative Site, Leeds

EC1A 7BE

Novartis Investigative Site, London

M20 4BX

Novartis Investigative Site, Manchester

PL6 8DH

Novartis Investigative Site, Plymouth

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY