A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

780

Participants

Timeline

Start Date

June 10, 2013

Primary Completion Date

December 9, 2016

Study Completion Date

December 31, 2019

Conditions
Gastric Cancer
Interventions
DRUG

5-Fluorouracil

Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m\^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.

DRUG

Capecitabine

Participants will receive capecitabine 1000 mg/m\^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.

DRUG

Cisplatin

Participants will receive cisplatin 80 mg/m\^2 IV q3w for 6 cycles.

DRUG

Pertuzumab

Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

DRUG

Placebo

Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

DRUG

Trastuzumab

Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Trial Locations (172)

100

National Taiwan Uni Hospital; Dept of Oncology, Taipei

112

Taipei Veterans General Hospital, Taipei

333

Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology, Taoyuan District

407

Taichung Veterans General Hospital; Dept of Surgery, Taichung

1000

University Clinic for Radiotherapy and Oncology, Skopje

1011

CHUV; Departement d'Oncologie, Lausanne

1083

Semmelweis Egyetem Onkologiai Központ, Budapest

1122

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

1301

MHAT Serdika, Sofia

3084

Austin Health; Cancer Clinical Trial Centre, Heidelberg

3168

Monash Medical Centre; Oncology, Clayton

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez, Miskolc

4004

Complex Oncological Center - Plovdiv, EOOD, Plovdiv

4029

Royal Brisbane Womens Hosp; Division of Oncology, Herston

4032

Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika, Debrecen

5020

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg

6004

Luzerner Kantonsspital; Medizinische Onkologie, Lucerne

6009

Sir Charles Gairdner Hospital; Medical Oncology, Perth

6511

Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin, Zams

6720

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged

7000

Clinical Hospital; Oncology Department, Bitola

9010

SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative, Varna

10000

Clinical Hospital Centre Zagreb, Zagreb

Clinical Hospital Sisters of Mercy, Zagreb

10065

Weill Medical College of Cornell University; Division of Hematology & Medical Oncology, New York

10117

Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo., Berlin

10400

Rajavithi Hospital; Division of Medical Oncology, Bangkok

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok

10700

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok

11366

Queens Medical Associates, Fresh Meadows

12206

New York Oncology Hematology, P.C., Albany

14000

Inst. Nacional de Cancerologia; Investigacion Clinica, Mexico City

14004

Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba

16150

Hospital Universiti Sains Malaysia [Neurology], Kubang Kerian

20132

Irccs Ospedale San Raffaele, Milan

20141

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milan

20246

Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum, Hamburg

20520

Turku Uni Central Hospital; Oncology Clinics, Turku

22770

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne

24127

Asst Papa Giovanni XXIII; Oncologia Medica, Bergamo

25240

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department, Erzurum

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

29425

Medical University of South Carolina; Hollings Cancer Center, Charleston

33100

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia, Udine

33901

Florida Cancer Specialists - SCRI; Pharmacy, Fort Myers

34300

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology, Istanbul

35043

Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie, Marburg

37203

Tennessee Oncology PLLC - Nashville (20th Ave), Nashville

40000

Khonkaen Hospital, Khonkaen

40138

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

41404

Kyungpook National University Medical Center, Daegu

42080

TC Necmettin Erbakan University Meram Medical Faculty Hospital, Konya

42100

AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia, Reggio Emilia

44280

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

45122

Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung, Essen

45136

Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie, Essen

45219

Oncology Hematology Care, Cincinnati

46526

Indiana University Health; Goshen Center for Cancer Care, Goshen

50586

Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi, Kuala Lumpur

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik, Mainz

56100

Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2, Pisa

59100

Ospedale Misericordia E Dolce; Oncologia Medica, Prato

University Malaya Medical Centre; Clinical Oncology Unit,, Kuala Lumpur

60121

Ospedali Riuniti Di Ancona; Oncology, Ancona

60637

University Of Chicago Medical Center; Section Of Hematology/Oncology, Chicago

68000

Oaxaca Site Management Organization, Oaxaca City

68167

Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum, Mannheim

71013

Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo

71640

Klinikum Ludwigsburg; Studiensekretariat, Ludwigsburg

73730

Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie, Esslingen am Neckar

80131

Seconda Universita' Degli Studi; Divsione Di Oncologia Medica, Napoli

88996

Hospital Wanita dan Kanak-Kanak Sabah, Sabah

89081

Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I, Ulm

89169

Comprehensive Cancer Centers of Nevada - Eastern Avenue, Las Vegas

90110

Songklanagarind Hospital; Department of Oncology, Songkhla

100021

Cancer Hospital Chinese Academy of Medical Sciences., Beijing

100071

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing

100142

Beijing Cancer Hospital, Beijing

110016

Fuzhou General Hospital, PLA Nanjing Military Area Command, Fuzhou

General Hospital of Shenyang Military Command of PLA, Shenyang

130021

the First Hospital of Jilin University, Changchun

132013

Jilin Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Zhongshan Hospital Fudan University, Shanghai

200120

Fudan University Shanghai Cancer Center, Shanghai

200347

Oncology Center Sf. Nectarie, Craiova

210002

The 81st Hospital of P.L.A., Nanjing

213003

Changzhou First People's Hospital, Changzhou

221000

The Affiliated Hospital of Xuzhou Medical College, Xuzhou

226001

Affiliated Hospital of Nantong University, Nantong

310016

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou

330006

The 1st Affiliated Hospital of Nanchang Unversity, Nanchang

390011

"SBI for HPE Ryazan State Medical University n.a. I.P. Pavlov of MoH of RF", Ryazan

400015

Cardiomed Medical Center, Cluj-Napoca

400042

Third Affiliated Hospital of Third Military Medical University, Chongqing

420029

Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan'

443031

SBI of Healthcare Samara Regional Clinical Oncology Dispensary, Samara

450008

Henan Cancer Hospital, Zhengzhou

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

510060

Sun Yet-sen University Cancer Center, Guangzhou

644013

Clinical Oncology Dispensary; Chemotherapy, Omsk

700106

Euroclinic Center of Oncology SRL, Iași

710032

The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital), Xi'an

22290-160

Clinicas Oncologicas Integradas - COI, Rio de Janeiro

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

Unknown

Hospital das Clinicas - UFRGS, Porto Alegre

Medical Research Centre, Panama City

88034-000

Centro de Pesquisas Oncologicas - CEPON, Florianópolis

01308-050

Hospital Sirio Libanes; Centro de Oncologia, São Paulo

01406100

Clinica de Oncologia Medica, São Paulo

01509-010

Hospital A. C. Camargo; Oncologia, São Paulo

22793-080

Universidade Federal de Sao Paulo - UNIFESP*X, São Paulo

P3E 5J1

Health Sciences North, Greater Sudbury

L8V 5C2

Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton

N6A 4L6

London Regional Cancer Centre, London

M4C 3E7

Toronto East General Hospital; Haematology/Oncology, Toronto

M4N 3M5

Sunnybrook Health Science Centre, Toronto

M5G 1X5

Mount Sinai Hospital; Oncology, Toronto

H4A 3J1

McGill University; Glen Site; Oncology, Montreal

050035

Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang

01101

Hospital Oncologia; Oncology, San Salvador

00180

Docrates Cance Center, Helsinki

04103

Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL), Leipzig

01-010

Medical Solution; Hematology, Guatemala City

00168

Policlinico Universitario Agostino Gemelli, Rome

464-8681

Aichi Cancer Center Hospital; Clinical Oncology, Aichi

466-8560

Nagoya university Hospital; Gastroenterological Surgery 2, Aichi

277-8577

National Cancer Center Hospital East; Gastroenterology, Chiba

791-0280

National Hospital Organization Shikoku Cancer Center; Gastroenterology, Ehime

812-8582

Kyushu University Hospital; Surgery and Science, Fukuoka

501-1194

Gifu University Hospital; Digestive Surgery, Gifu

730-8518

Hiroshima City Hiroshima Citizens Hospital; Surgery, Hiroshima

650-0047

Kobe city Medical center General Hospital; Medical Oncology, Hyōgo

216-8511

St.Marianna University School of Medicine hospital; Medical Oncology, Kanagawa

241-8515

Kanagawa Cancer Center; Gastrointestinal Surgery, Kanagawa

541-8567

Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology, Osaka

558-8558

Osaka General Medical Center; Gastroenterological Surgery, Osaka

362-0806

Saitama Cancer Center; Gastroenterology, Saitama

104-0045

National Cancer Center Hospital; Gastrointestinal Oncology, Tokyo

930-0194

Toyama University Hospital;Gastroenterology and Hematology, Toyama

050022

Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department, Almaty

06760

Hospital Angeles Metropolitano; Room 220, Mexico City

1105 AZ

Academisch Medisch Centrum Universiteit Amsterdam, Amsterdam

04001

Centro Medico Monte Carmelo, Arequipa

02

Hospital Sabogal; Oncology, Callao

Lima 11

Hosp Nacion Edgardo Rebagliati; Oncologia Medica, Jesus Maria

Lima 41

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional, Lima

Clinica San Borja, Lima

15-027

Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej, Bialystok

36-200

Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny, Brzozów

85-796

Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii, Bydgoszcz

30-688

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii, Krakow

45-060

SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego, Opole

61-485

NZOZ Centrum Medyczne HCP Sp. z o.o., Poznan

44-200

Wojewódzki Szpital Specjalistyczny Nr 3, Rybnik

02-781

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej, Warsaw

(0)6351

Samsung Medical Center, Seoul

03080

Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul

03722

Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology, Seoul

05505

Asan Medical Center; Medical Oncology, Seoul

06591

Seoul St Mary's Hospital, Seoul

03203

Hospital General Universitario de Elche; Servicio de Oncologia, Elche

08916

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

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

08035

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona

08041

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona

08907

Hospital Duran i Reynals; Oncologia, Barcelona

00704

National Cheng Kung University Hospital; Oncology, Tainan City

06590

Ankara Uni School of Medicine; Medical Oncology, Ankara

07070

Akdeniz University Medical Faculty; Medical Oncology Department, Antalya

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01774786 - A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer | Biotech Hunter | Biotech Hunter