NCT01160211 - A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer | Biotech Hunter

Enrollment

369

Participants

Timeline

Start Date

May 5, 2011

Primary Completion Date

March 11, 2016

Study Completion Date

June 6, 2022

Conditions

Neoplasms, Breast

Interventions

DRUG

Lapatinib

1000 mg by mouth once a day

DRUG

Trastuzumab

Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks)

DRUG

Aromatase Inhibitor

Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily

DRUG

Lapatinib

1500 mg by mouth once daily

Trial Locations (110)

500

Novartis Investigative Site, Changhua

833

Novartis Investigative Site, Kaohsiung City

1330

Novartis Investigative Site, Sofia

1756

Novartis Investigative Site, Sofia

1878

Novartis Investigative Site, Quilmes

2640

Novartis Investigative Site, Albury

3000

Novartis Investigative Site, Leuven

3526

Novartis Investigative Site, Miskolc

4004

Novartis Investigative Site, Plovdiv

4400

Novartis Investigative Site, Nyíregyháza

4814

Novartis Investigative Site, Douglas

5000

Novartis Investigative Site, Namur

5700

Novartis Investigative Site, Gyula

6720

Novartis Investigative Site, Szeged

7400

Novartis Investigative Site, Kaposvár

7624

Novartis Investigative Site, Pécs

9010

Novartis Investigative Site, Varna

10000

Novartis Investigative Site, Zagreb

10408

Novartis Investigative Site, Gyeonggi-do

11000

Novartis Investigative Site, Belgrade

11217

Novartis Investigative Site, Taipei

12002

Novartis Investigative Site, Castellon

15009

Novartis Investigative Site, A Coruña

15517

Novartis Investigative Site, Fürstenwalde

20089

Novartis Investigative Site, Rozzano (MI)

21029

Novartis Investigative Site, Vinnitsia

21204

Novartis Investigative Site, Kamenitz

25030

Novartis Investigative Site, Besançon

28040

Novartis Investigative Site, Madrid

30912

Novartis Investigative Site, Augusta

31000

Novartis Investigative Site, Osijek

31096

Novartis Investigative Site, Haifa

33021

Novartis Investigative Site, Hollywood

34298

Novartis Investigative Site, Montpellier

35100

Novartis Investigative Site, Izmir

38138

Novartis Investigative Site, Germantown

38642

Novartis Investigative Site, Goslar

40005

Novartis Investigative Site, Sumy

42551

Novartis Investigative Site, Velbert

52621

Novartis Investigative Site, Ramat Gan

53840

Novartis Investigative Site, Troisdorf

58013

Novartis Investigative Site, Chernivtsi

61070

Novartis Investigative Site, Kharkiv

68100

Novartis Investigative Site, Alexandroupoli

71110

Novartis Investigative Site, Heraklion

73100

Novartis Investigative Site, Chania

75970

Novartis Investigative Site, Paris

81675

Novartis Investigative Site, Munich

88000

Novartis Investigative Site, Uzhhorod

91120

Novartis Investigative Site, Jerusalem

98405

Novartis Investigative Site, Tacoma

115478

Novartis Investigative Site, Moscow

130021

Novartis Investigative Site, Changchun

150081

Novartis Investigative Site, Harbin

163045

Novartis Investigative Site, Arkhangelsk

197022

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

200032

Novartis Investigative Site, Shanghai

308433

Novartis Investigative Site, Singapore

350001

Novartis Investigative Site, Fuzhou

390011

Novartis Investigative Site, Ryazan

420029

Novartis Investigative Site, Kazan'

440010

Novartis Investigative Site, Nagpur

510060

Novartis Investigative Site, Guangzhou

B1880BBF

Novartis Investigative Site, Berazategui

C1417DTN

Novartis Investigative Site, Capital Federal

C1050AAK

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires

C1280AEB

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires

B1920CMK

Novartis Investigative Site, La Plata

R8500ACE

Novartis Investigative Site, Viedma

S2000KZE

Novartis Investigative Site, Rosario

X5004FHP

Novartis Investigative Site, Córdoba

F5300COE

Novartis Investigative Site, La Rioja

T4000IAK

Novartis Investigative Site, San Miguel de Tucumán

74605-070

Novartis Investigative Site, Goiânia

90470-340

Novartis Investigative Site, Porto Alegre

91350-200

Novartis Investigative Site, Porto Alegre

14784-400

Novartis Investigative Site, Barretos

01317-001

Novartis Investigative Site, São Paulo

03102-002

Novartis Investigative Site, São Paulo

05651-901

Novartis Investigative Site, São Paulo

20560-120

Novartis Investigative Site, Rio de Janeiro

Unknown

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Kowloon

Novartis Investigative Site, Tuenmen

Novartis Investigative Site, Arequipa

H-9024

Novartis Investigative Site, Győr

H-8900

Novartis Investigative Site, Zalaegerszeg

110 092

Novartis Investigative Site, New Delhi

464-8681

Novartis Investigative Site, Aichi

277-8577

Novartis Investigative Site, Chiba

791-0280

Novartis Investigative Site, Ehime

537-8511

Novartis Investigative Site, Osaka

540-0006

Novartis Investigative Site, Osaka

362-0806

Novartis Investigative Site, Saitama

104-8560

Novartis Investigative Site, Tokyo

Lima 18

Novartis Investigative Site, Lima

62-500

Novartis Investigative Site, Konin

04-125

Novartis Investigative Site, Warsaw

1400-038

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08036

Novartis Investigative Site, Barcelona

06200

Novartis Investigative Site, Ankara

07352

Novartis Investigative Site, Liutizh

SW3 6JJ

Novartis Investigative Site, London

ME16 9QQ

Novartis Investigative Site, Maidstone

PE3 9GZ

Novartis Investigative Site, Peterborough