A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

February 17, 2012

Primary Completion Date

March 17, 2016

Study Completion Date

November 14, 2019

Conditions
Breast Cancer
Interventions
DRUG

Pertuzumab

Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity.

DRUG

Trastuzumab

Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.

DRUG

Aromatase Inhibitor

Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.

DRUG

Induction Chemotherapy

Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.

Trial Locations (82)

10003

Hospital de San Pedro de Alcantara, Cáceres

11042

NS-Long Island Jewish Hlth Sys, Lake Success

ProHEALTH Care Associates LLP, Lake Success

12002

Hospital Provincial de Castellon; Servicio de Oncologia, Castellon

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

15006

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, A Coruña

15009

Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia, A Coruña

15232

UPMC Cancer Centers, Pittsburgh

20014

IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia, Donostia / San Sebastian

20080

Hospital de Donostia; Servicio de Oncologia Medica, Donostia / San Sebastian

20133

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milan

20817

Center For Cancer and Blood Disorders, Bethesda

21053

Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica, Castellanza

21237

Weinberg CA Inst Franklin Sq, Baltimore

25030

HOPITAL JEAN MINJOZ; Oncologie, Besançon

25198

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lleida

27100

IRCCS Fondazione Maugeri; Oncologia Medica I, Pavia

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28040

Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid

29609

Hopital Morvan; Oncologie - Radiotherapie, Brest

30060

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta

30120

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia, Murcia

30341

Georgia Cancer Specialists - Northside, Atlanta

31076

Clinique Pasteur; Oncologie Medicale, Toulouse

33000

Clinique Tivoli; Sce Radiotherapie, Bordeaux

33170

A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica, Pordenone

33176

Advanced Medical Specialties, Miami

35100

Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir

35249

University of Alabama at Birmingham, Birmingham

40138

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna

41009

Hospital Universitario Virgen Macarena; Servicio de Oncologia, Seville

43100

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica, Parma

44202

Centre Catherine de Sienne; Chimiotherapie, Nantes

44280

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

50009

Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza

50139

A.O. Careggi; Radioterapia, Florence

54519

Centre Alexis Vautrin; Oncologie Medicale, Vandœuvre-lès-Nancy

59100

Ospedale Misericordia E Dolce; Oncologia Medica, Prato

60309

CH De Senlis; Medecine 2, Senlis

63011

Centre Jean Perrin; Oncologie, Clermont-Ferrand

63110

Washington University School of Medicine; Internal Medicine - Renal, St Louis

69337

Clinique De La Sauvegarde; Chimiotherapie, Lyon

70072

Crescent City Rsrch Cnsrtm, LLC, Marrero

70124

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica, Bari

71913

Genesis Cancer Center, Hot Springs

72100

Ospedale Antonio Perrino; Oncologia Medica, Brindisi

73100

Ospedale Vito Fazzi; Div. Oncoematologia, Lecce

76508

Scott and White Hospital; Cancer Center, Temple

77030

Baylor College of Medicine; Lester & Sue Smith Breast Ctr, Houston

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

Università degli Studi Federico II; Clinica di Oncologia Medica, Napoli

80220

Rocky Mountain Cancer Center - Denver, Denver

85224

Ironwood Cancer TX & Rsch Ctrs, Chandler

93309

Comprehensive Blood & CA Ctr; Research, Bakersfield

95122

Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica, Catania

110076

Indraprastha Apollo Hospitals, New Delhi

400026

Jaslok Hospital & Research Centre; Medical Oncology, Mumbai

560027

Bangalore Institute of Oncology, Bangalore

600035

Apollo Speciality Hospital, Chennai

06856

Norwalk Hospital, Norwalk

67214-3728

Cancer Center of Kansas, Wichita

07960

Hematology Oncology Associates; Carol G. Simon Ctr, Morristown

08043

Cooper Hospital; Hematology & Oncology, Voorhees Township

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

01317-904

Hospital Perola Byington, São Paulo

03102-002

Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia, São Paulo

CEP 01321-001

Hospital Sao Jose, São Paulo

06189

Centre Antoine Lacassagne; Hopital De Jour A2, Nice

411 001

Ruby Hall Clinic, Pune

03039

Ospedale S.S. Trinità Nuovo; Divisione Oncologia, Sora

08916

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

06100

Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Ankara

06490

Ankara City Hospital, Ankara

BN2 5BE

Brighton and Sussex Univ Hosp, Brighton

CV2 2DX

University Hospital coventry; Oncology Department, Coventry

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

SE18 4QH

Queen Elizabeth Hospital, London

PO6 3LY

Queen Alexandra Hospital, Portsmouth, Portsmouth

YO12 6QL

Scarborough General Hospital, Scarborough

S10 2SJ

Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01491737 - A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer | Biotech Hunter | Biotech Hunter