Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

May 6, 2015

Primary Completion Date

February 22, 2019

Study Completion Date

February 22, 2019

Conditions
Breast Cancer
Interventions
DRUG

Docetaxel

Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.

DRUG

pertuzumab [Perjeta]

Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg

DRUG

trastuzumab [Herceptin]

Subcutaneous administration of 600 mg/5 mL every 3 weeks

Trial Locations (112)

1032

Szent Margit Hospital; Dept. of Oncology, Budapest

1051

Ogyi, Orszagos Gyogyszereszeti Intezet, Budapest

1083

Semmelweis Egyetem, Budapest

1090

UZ Brussel, Brussels

1115

Szent Imre Egyetemi Oktatokorhaz, Budapest

1122

Orszagos Onkologiai Intezet, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

1233

Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD, Sofia

2610

Sint Augustinus Wilrijk, Wilrijk

3000

MDOZS Vrasta Ltd., Vratsa

3526

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Miskolc

4000

CHU Sart-Tilman, Liège

Clinique Saint-Joseph, Liège

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD, Plovdiv

4002

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv

4004

Comprehensive Cancer Center-Plovdiv, Plovdiv

5300

Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC, Gabrovo

8000

AZ Sint Jan, Bruges

9010

Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd, Varna

10317

Onkologische Schwerpunktpraxis Dr. Joerg Schilling, Berlin

13003

Hopital Europeen, Marseille

14004

Hospital Universitario Reina Sofia, Córdoba

15706

Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario, Santiago de Compostela

16132

Ospedale Policlinico San Martino, Genoa

20089

Istituto Clinico Humanitas, Rozzano (MI)

Azienda Ospedaliera Santa Maria di Terni, Terni

20141

Istituto Europeo Di Oncologia, Milan

21000

Centre Georges Francois Leclerc, Dijon

23100

Asst Della Valtellina E Dell'Alto Lario, Sondrio

23538

Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I, Lübeck

23562

Onkologische Schwerpunktpraxis Lübeck, Lübeck

24100

Asst Papa Giovanni XXIII, Bergamo

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital General Universitario Gregorio Maranon, Madrid

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Madrid

28630

Centre Hospitalier Louis Pasteur, Chartes Le Coudray

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

37024

Ospedale Sacro Cuore Don Calabria, Negrar

37124

"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento", Verona

38028

Groupe Hospitalier Mutualiste de Grenoble, Grenoble

38043

CHU de Grenoble, Grenoble

39576

Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie, Stendal

40024

Centre Hospitalier de Mont de Marsan - Hopital Layne, Mont-de-Marsan

41110

Azienda Ospedaliero - Universitaria di Modena Policlinico, Modena

42123

Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova, Reggio Emilia

44124

Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, Cona (Ferrara)

45136

Kliniken Essen-Mitte, Essen

45147

Universitätsklinikum Essen, Essen

46009

Fundacion Instituto Valenciano de Oncologia (IVO), Valencia

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola

47900

Ospedale Infermi di Rimini, Rimini

50012

Ospedale Santa Maria Annunziata, Bagno a Ripoli

50141

Azienda Ospedaliera Universitaria Careggi, Florence

54290

Klinikum Mutterhaus der Borromaeerinnen, Trier

55101

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

56100

Azienda USL 5 di Pisa, Pisa

57530

Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy, Ars-Laquenexy

59100

Ospedale Santo Stefano, Azienda USL Centro Prato, Prato

63050

Pole Sante Republique; Pharmacie Oncologique, Clermont-Ferrand

63069

Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe, Offenbach

63739

Studienzentrum Aschaffenburg, Aschaffenburg

64710

Centro Medico San Jose, Monterrey, Nuevo Leon

67000

Strasbourg Oncologie Libérale, Strasbourg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

71100

Hopital Prive Sainte Marie, Chalon-sur-Saône

73190

Medipole De Savoie; Departement Oncologie, Challes-les-Eaux

75674

Hopital Saint Joseph; Service de Rhumatologie, Paris

76090

Cancerología, Querétaro

79110

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau

85100

Azienda Ospedaliera Regionale San Carlo, Potenza

91054

Universitaetsklinikum Erlangen, Erlangen

94800

Gustave Roussy, Villejuif

95123

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele, Catania

97080

Universitätsklinikum Würzburg, Würzburg

99734

Suedharz Klinikum Nordhausen gGmbH, Nordhausen

625000

Przychodnia Lekarska KOMED, Konin

E1C 6Z8

Moncton Hospital, Moncton

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

H-1077

Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely, Budapest

00144

Istituti Fisioterapici Ospitalieri, Rome

03100

Consultorio de Medicina Especializada, México

03310

Grupo Medico Camino, DF

06760

Superare Centro de Infusion S.A. de C.V., México

Unknown

Fundacion de Cancer de Mama.A.C., México

15-027

Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie, Bialystok

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

80-219

Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk

81-519

Szpitale Pomorskie Sp. z o. o., Gdynia

31-501

Szpital Uniwersytecki w Krakowie, Krakow

20-090

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin

10-228

Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie, Olsztyn

45-061

Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii, Opole

60-569

Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna, Poznan

61-866

Wielkopolskie Centrum Onkologii, Poznan

00-973

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna, Warsaw

04-125

MAGODENT Sp. z o.o., Warsaw

4710-243

Hospital de Braga, Braga

3000-075

Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE, Coimbra

1500-650

Hospital da Luz, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria, Lisbon

4200-072

IPO do Porto; Servico de Oncologia Medica, Porto

08035

Hospital Universitari Vall d'Hebron, Barcelona

LL57 2PW

Betsi Cadwaladr University Health Board, Bangor Gwynedd

CF14 2TL

Velindre Cancer Centre, Cardiff

DT1 2JY

Dorset County Hospital, Dorchester

LE1 5WW

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary, Leicester

SE1 9RT

Guys and St Thomas NHS Foundation Trust, Guys Hospital, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

HA6 2RN

Mount Vernon Cancer Centre, Northwood

PE3 9GZ

Peterborough City Hospital, Peterborough

PO6 3LY

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital, Portsmouth

TR1 3LJ

Royal Cornwall Hospitals NHS Trust, Truro

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02402712 - Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer | Biotech Hunter | Biotech Hunter