Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

719

Participants

Timeline

Start Date

September 10, 2009

Primary Completion Date

May 30, 2014

Study Completion Date

October 23, 2017

Conditions
Breast Cancer
Interventions
DRUG

Everolimus

Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

DRUG

Placebo

Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

DRUG

Trastuzumab

Trastuzumab, 2 mg/kg weekly was used intravenously.

DRUG

Paclitaxel

Paclitaxel, 80 mg/m2 weekly was used intravenously.

Trial Locations (140)

34

Novartis Investigative Site, Surquillo

41

Novartis Investigative Site, San Borja

1211

Novartis Investigative Site, Geneva

1417

Novartis Investigative Site, Capital Federal

2001

Novartis Investigative Site, Valencia

2610

Novartis Investigative Site, Wilrijk

3165

Novartis Investigative Site, East Bentleigh

3500

Novartis Investigative Site, Hasselt

4091

Novartis Investigative Site, Durban

4215

Novartis Investigative Site, Southport

4800

Novartis Investigative Site, Verviers

5530

Novartis Investigative Site, Yvoir

6000

Novartis Investigative Site, Charleroi

8038

Novartis Investigative Site, Zurich

8500

Novartis Investigative Site, Rio Negro

9301

Novartis Investigative Site, Bloemfontein

10002

Novartis Investigative Site, Taipei

10003

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

10098

Novartis Investigative Site, Berlin

10408

Novartis Investigative Site, Gyeonggi-do

11217

Novartis Investigative Site, Taipei

12208

New York Oncology Hematology NYOH Amsterdam, Albany

18547

Novartis Investigative Site, Athens

20900

Novartis Investigative Site, Monza

23230

Virginia Cancer Institute VCI (3), Richmond

23502

Virginia Oncology Associates SC, Norfolk

24105

Novartis Investigative Site, Kiel

31059

Novartis Investigative Site, Toulouse

33305

Novartis Investigative Site, Taoyuan District

33401

Florida Cancer Specialists, West Palm Beach

33901

Florida Cancer Specialists Dept.of FloridaCancerSpec. (2), Fort Myers

34662

Novartis Investigative Site, Altunizade

35012

Novartis Investigative Site, Camposampiero

35040

Novartis Investigative Site, Izmir

35340

Novartis Investigative Site, Izmir

36688

University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst., Mobile

37203

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

40447

Novartis Investigative Site, Taichung

41124

Novartis Investigative Site, Modena

44805

Novartis Investigative Site, Saint-Herblain Cédex

46227

Central Indiana Cancer Centers CICC - East (3), Indianapolis

48149

Novartis Investigative Site, Münster

51000

Novartis Investigative Site, Guangzhou

66210

Kansas City Cancer Center Dept. of KCCC, Overland Park

68198

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

72703

Highlands Oncology Group, Fayetteville

73730

Novartis Investigative Site, Esslingen am Neckar

74203

Novartis Investigative Site, Thonon-les-Bains

75246

Texas Oncology Charles A. Sammons Cancer Ctr, Dallas

75251

Texas Oncology P A SC-Austin, Dallas

75702

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

76000

Novartis Investigative Site, Rouen

80131

Novartis Investigative Site, Napoli

80756

Novartis Investigative Site, Kaohsiung City

85224

Ironwood Cancer and Research Centers, Chandler

87000

Novartis Investigative Site, Limoges

90095

University of California at Los Angeles Dept. of UCLA, Los Angeles

90277

Cancer Care Associates Medical Group Dept. of CCA, Redondo Beach

91910

Novartis Investigative Site, Zaragoza

92835

St. Jude Heritage Medical Group Virginia Crosson Cancer Center, Fullerton

93030

Ventura County Hematology and Oncology, Oxnard

93105

Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc, Santa Barbara

93309

Comprehensive Blood and Cancer Center Dept. of CBCC (2), Bakersfield

93454

Central Coast Medical Oncology Corporation Onc Dept, Santa Maria

94805

Novartis Investigative Site, Villejuif

97210

Northwest Cancer Specialists Vancouver Cancer Center (3), Portland

100021

Novartis Investigative Site, Beijing

100039

Novartis Investigative Site, Beijing

115478

Novartis Investigative Site, Moscow

129128

Novartis Investigative Site, Moscow

143423

Novartis Investigative Site, Moscow

150081

Novartis Investigative Site, Harbin

166830

Novartis Investigative Site, El Achrafiyé

197758

Novartis Investigative Site, Saint Petersburg

198255

Novartis Investigative Site, Saint Petersburg

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

210002

Novartis Investigative Site, Nanjing

210009

Novartis Investigative Site, Nanjing

310022

Novartis Investigative Site, Hangzhou

420029

Novartis Investigative Site, Kazan'

510060

Novartis Investigative Site, Guangzhou

Unknown

Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3), Greenwood Village

Novartis Investigative Site, Posadas

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Florida Blanca

Novartis Investigative Site, Montería

Novartis Investigative Site, Alexandria

Novartis Investigative Site, Cairo

Novartis Investigative Site, Shatin, New Territories

Novartis Investigative Site, Hong Kong SAR

Novartis Investigative Site, Tuenmen

Novartis Investigative Site, Wilton

Novartis Investigative Site, Dublin

C1050AAK

Novartis Investigative Site, CABA

B7600CTO

Novartis Investigative Site, Mar del Plata

S200KZE

Novartis Investigative Site, Rosario

X5004BAL

Novartis Investigative Site, Córdoba

30130-100

Novartis Investigative Site, Belo Horizonte

30380-490

Novartis Investigative Site, Belo Horizonte

20230-130

Novartis Investigative Site, Rio de Janeiro

01246 000

Novartis Investigative Site, São Paulo

04038-001

Novartis Investigative Site, São Paulo

H2W 1S6

Novartis Investigative Site, Montreal

H4J 1C5

Novartis Investigative Site, Montreal

J7Z 5T3

Novartis Investigative Site, Saint-Jérôme

0000

Novartis Investigative Site, Bogota

F 67098

Novartis Investigative Site, Strasbourg

09113

Novartis Investigative Site, Chemnitz

711 10

Novartis Investigative Site, Heraklion Crete

151 23

Novartis Investigative Site, Athens

564 03

Novartis Investigative Site, Thessaloniki

115 28

Novartis Investigative Site, Athens

00128

Novartis Investigative Site, Roma

464-8681

Novartis Investigative Site, Nagoya

277-8577

Novartis Investigative Site, Kashiwa

811-1395

Novartis Investigative Site, Fukuoka

802-0077

Novartis Investigative Site, Kitakyushu

371 8511

Novartis Investigative Site, Maebashi

060 8648

Novartis Investigative Site, Sapporo

259-1193

Novartis Investigative Site, Isehara

860-8556

Novartis Investigative Site, Kumamoto

606 8507

Novartis Investigative Site, Sakyo-ku

540-0006

Novartis Investigative Site, Osaka

565 0871

Novartis Investigative Site, Suita

362-0806

Novartis Investigative Site, Kitaadachi-gun

113-8677

Novartis Investigative Site, Bunkyo-ku

104-8560

Novartis Investigative Site, Chuo-ku

537-8511

Novartis Investigative Site, Osaka

1107 2020

Novartis Investigative Site, Beirut

04980

Novartis Investigative Site, Mexico City

00921

San Juan VA Hospital San Juan Hospital, San Juan

0002

Novartis Investigative Site, Pretoria

06351

Novartis Investigative Site, Seoul

02841

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

06100

Novartis Investigative Site, Ankara

TR1 3LJ

Novartis Investigative Site, Truro

SW3 6JJ

Novartis Investigative Site, London

SM2 5PT

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY