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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 (JACOB)

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5-Fluorouracil
Capecitabine
Cisplatin
Pertuzumab
Placebo
Trastuzumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed metastatic adenocarcinoma of the stomach or GEJ
  • Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy greater than equal to (>/=) 3 months

Exclusion Criteria:

  • Previous cytotoxic chemotherapy for advanced (metastatic) disease
  • Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
  • Previous treatment with any HER2-directed therapy, at any time, for any duration
  • Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
  • Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to bone metastases, if recovered from all toxicities)
  • History or evidence of brain metastases
  • Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])
  • Residual toxicity resulting from previous therapy (for example, hematologic, cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted
  • Other malignancy (in addition to gastric cancer [GC]) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
  • Inadequate hematologic, renal or liver function
  • Pregnant or lactating women
  • History of congestive heart failure of any New York Heart Association (NYHA) criteria
  • Angina pectoris requiring treatment
  • Myocardial infarction within the past 6 months before the first dose of study drug
  • Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
  • History or evidence of poorly controlled hypertension
  • Baseline left ventricular ejection fraction (LVEF) value less than (<) 55 percent (%)
  • Any significant uncontrolled intercurrent systemic illness
  • Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

Sites / Locations

  • Florida Cancer Specialists - SCRI; Pharmacy
  • University Of Chicago Medical Center; Section Of Hematology/Oncology
  • Indiana University Health; Goshen Center for Cancer Care
  • Comprehensive Cancer Centers of Nevada - Eastern Avenue
  • New York Oncology Hematology, P.C.
  • Queens Medical Associates
  • Weill Medical College of Cornell University; Division of Hematology & Medical Oncology
  • Oncology Hematology Care
  • Medical University of South Carolina; Hollings Cancer Center
  • Tennessee Oncology PLLC - Nashville (20th Ave)
  • Royal Brisbane Womens Hosp; Division of Oncology
  • Monash Medical Centre; Oncology
  • Austin Health; Cancer Clinical Trial Centre
  • Sir Charles Gairdner Hospital; Medical Oncology
  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin
  • Cliniques Universitaires St-Luc
  • Clinicas Oncologicas Integradas - COI
  • Hospital Nossa Senhora da Conceicao
  • Hospital das Clinicas - UFRGS
  • Centro de Pesquisas Oncologicas - CEPON
  • Hospital Sirio Libanes; Centro de Oncologia
  • Clinica de Oncologia Medica
  • Hospital A. C. Camargo; Oncologia
  • Universidade Federal de Sao Paulo - UNIFESP*X
  • Complex Oncological Center - Plovdiv, EOOD
  • MHAT Serdika
  • SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative
  • Hamilton Health Sciences - Juravinski Cancer Centre
  • London Regional Cancer Centre
  • Health Sciences North
  • Toronto East General Hospital; Haematology/Oncology
  • Sunnybrook Health Science Centre
  • Mount Sinai Hospital; Oncology
  • McGill University; Glen Site; Oncology
  • Cancer Hospital Chinese Academy of Medical Sciences.
  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
  • Beijing Cancer Hospital
  • the First Hospital of Jilin University
  • Jilin Cancer Hospital
  • Changzhou First People's Hospital
  • Third Affiliated Hospital of Third Military Medical University
  • Fuzhou General Hospital, PLA Nanjing Military Area Command
  • Sun Yet-sen University Cancer Center
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  • Harbin Medical University Cancer Hospital
  • The 1st Affiliated Hospital of Nanchang Unversity
  • The 81st Hospital of P.L.A.
  • Affiliated Hospital of Nantong University
  • Zhongshan Hospital Fudan University
  • Fudan University Shanghai Cancer Center
  • General Hospital of Shenyang Military Command of PLA
  • Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
  • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
  • The Affiliated Hospital of Xuzhou Medical College
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Clinical Hospital Centre Zagreb
  • Clinical Hospital Sisters of Mercy
  • Hospital Oncologia; Oncology
  • Docrates Cance Center
  • Turku Uni Central Hospital; Oncology Clinics
  • Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
  • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
  • Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
  • Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum
  • Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)
  • Klinikum Ludwigsburg; Studiensekretariat
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik
  • Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
  • Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
  • Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
  • Medical Solution; Hematology
  • Semmelweis Egyetem Onkologiai Központ
  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
  • Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
  • Policlinico Universitario Agostino Gemelli
  • Asst Papa Giovanni XXIII; Oncologia Medica
  • Irccs Ospedale San Raffaele
  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
  • Ospedali Riuniti Di Ancona; Oncology
  • Ospedale Casa Sollievo Della Sofferenza IRCCS
  • Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
  • Ospedale Misericordia E Dolce; Oncologia Medica
  • Aichi Cancer Center Hospital; Clinical Oncology
  • Nagoya university Hospital; Gastroenterological Surgery 2
  • National Cancer Center Hospital East; Gastroenterology
  • National Hospital Organization Shikoku Cancer Center; Gastroenterology
  • Kyushu University Hospital; Surgery and Science
  • Gifu University Hospital; Digestive Surgery
  • Hiroshima City Hiroshima Citizens Hospital; Surgery
  • Kobe city Medical center General Hospital; Medical Oncology
  • St.Marianna University School of Medicine hospital; Medical Oncology
  • Kanagawa Cancer Center; Gastrointestinal Surgery
  • Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology
  • Osaka General Medical Center; Gastroenterological Surgery
  • Saitama Cancer Center; Gastroenterology
  • National Cancer Center Hospital; Gastrointestinal Oncology
  • Toyama University Hospital;Gastroenterology and Hematology
  • Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
  • Kyungpook National University Medical Center
  • Samsung Medical Center
  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
  • Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
  • Asan Medical Center; Medical Oncology
  • Seoul St Mary's Hospital
  • Hospital Universiti Sains Malaysia [Neurology]
  • Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
  • University Malaya Medical Centre; Clinical Oncology Unit,
  • Hospital Wanita dan Kanak-Kanak Sabah
  • Hospital Angeles Metropolitano; Room 220
  • Inst. Nacional de Cancerologia; Investigacion Clinica
  • Oaxaca Site Management Organization
  • Academisch Medisch Centrum Universiteit Amsterdam
  • Clinical Hospital; Oncology Department
  • University Clinic for Radiotherapy and Oncology
  • Medical Research Centre
  • Centro Medico Monte Carmelo
  • Hospital Sabogal; Oncology
  • Hosp Nacion Edgardo Rebagliati; Oncologia Medica
  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
  • Clinica San Borja
  • Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
  • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
  • NZOZ Centrum Medyczne HCP Sp. z o.o.
  • Wojewódzki Szpital Specjalistyczny Nr 3
  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
  • Cardiomed Medical Center
  • Oncology Center Sf. Nectarie
  • Euroclinic Center of Oncology SRL
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • Clinical Oncology Dispensary; Chemotherapy
  • SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
  • SBI of Healthcare Samara Regional Clinical Oncology Dispensary
  • Hospital General Universitario de Elche; Servicio de Oncologia
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Hospital del Mar; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Hospital Duran i Reynals; Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • CHUV; Departement d'Oncologie
  • Luzerner Kantonsspital; Medizinische Onkologie
  • Taichung Veterans General Hospital; Dept of Surgery
  • National Cheng Kung University Hospital; Oncology
  • Taipei Veterans General Hospital
  • National Taiwan Uni Hospital; Dept of Oncology
  • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
  • Rajavithi Hospital; Division of Medical Oncology
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Khonkaen Hospital
  • Songklanagarind Hospital; Department of Oncology
  • Ankara Uni School of Medicine; Medical Oncology
  • Akdeniz University Medical Faculty; Medical Oncology Department
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • TC Necmettin Erbakan University Meram Medical Faculty Hospital
  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pertuzumab + Trastuzumab + Chemotherapy

Placebo + Trastuzumab + Chemotherapy

Arm Description

Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Participants will receive placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival (OS) was defined as the time from randomization to death from any cause. For participants who were still alive on the date of clinical data cut-off for the OS analysis, the last date when the participant was known to be alive on, or prior to the clinical cut-off date, was used to determine the censoring date. Participants who did not have any post-baseline data (e.g., dosing records, imaging dates, visit dates) were censored at the date of randomization plus 1 day.

Secondary Outcome Measures

Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria
Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Tumor assessments with CT or MRI scans of the chest, abdomen, and pelvis were performed every 9 weeks. Participants without documented PD or death were censored at the tumor assessment date for which the participant was last known to be progression-free. Participants who did not have any post-baseline tumor assessment data were censored at the date of randomization plus 1 day. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 millimeters (mm) in the sum of diameters of target lesions; the appearance of one or more new lesions.
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.
Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria
Duration of objective response is defined as the time from first occurrence of documented objective response to documented disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Objective response: PR or CR occurring on 2 consecutive occasions ≥4 weeks apart. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. Measurable disease defined as tumor lesions with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node, it must be ≥15 mm in short axis when assessed by CT scan.
Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria
The clinical benefit rate was defined as best response of complete response (CR) or partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the investigator using RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters while on study. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be >/=15 mm in short axis when assessed by CT scan. The clinical benefit rate was not updated at the final analysis.
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. The investigator graded all AEs for severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD)
The number and percentage of participants with symptomatic left ventricular systolic dysfunction (LVSD) and asymptomatic LVSD events (defined as a left ventricular ejection fraction [LVEF] ≥10% decrease from baseline to an absolute value <50%) at any time during the study was summarized by treatment arm.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score
The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. A positive value means an increase, while a negative values means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Maximum Serum Concentration (Cmax) of Pertuzumab
Cmax of Trastuzumab
Minimum Serum Concentration (Cmin) of Pertuzumab
Cmin of Trastuzumab

Full Information

First Posted
January 21, 2013
Last Updated
December 3, 2020
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01774786
Brief Title
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
Acronym
JACOB
Official Title
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2013 (Actual)
Primary Completion Date
December 9, 2016 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
780 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pertuzumab + Trastuzumab + Chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Arm Title
Placebo + Trastuzumab + Chemotherapy
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive cisplatin 80 mg/m^2 IV q3w for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta, RO4368451
Intervention Description
Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin, RO0452317
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) was defined as the time from randomization to death from any cause. For participants who were still alive on the date of clinical data cut-off for the OS analysis, the last date when the participant was known to be alive on, or prior to the clinical cut-off date, was used to determine the censoring date. Participants who did not have any post-baseline data (e.g., dosing records, imaging dates, visit dates) were censored at the date of randomization plus 1 day.
Time Frame
From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months)
Secondary Outcome Measure Information:
Title
Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria
Description
Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Tumor assessments with CT or MRI scans of the chest, abdomen, and pelvis were performed every 9 weeks. Participants without documented PD or death were censored at the tumor assessment date for which the participant was last known to be progression-free. Participants who did not have any post-baseline tumor assessment data were censored at the date of randomization plus 1 day. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 millimeters (mm) in the sum of diameters of target lesions; the appearance of one or more new lesions.
Time Frame
Baseline to death or progressive disease (PD), whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] vs. 21.3 [0-39] months; Final Analysis: 50.4 [0-70] vs. 47.4 [0-66] months)
Title
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
Description
The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.
Time Frame
Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] months vs. 21.3 [0-39] months)
Title
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
Description
The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.
Time Frame
Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Final Analysis: 50.4 [0-70] months vs. 47.4 [0-66] months)
Title
Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria
Description
Duration of objective response is defined as the time from first occurrence of documented objective response to documented disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Objective response: PR or CR occurring on 2 consecutive occasions ≥4 weeks apart. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. Measurable disease defined as tumor lesions with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node, it must be ≥15 mm in short axis when assessed by CT scan.
Time Frame
Baseline to death or progressive disease (PD), whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] vs. 21.3 [0-39] months; Final Analysis: 50.4 [0-70] vs. 47.4 [0-66] months)
Title
Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria
Description
The clinical benefit rate was defined as best response of complete response (CR) or partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the investigator using RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters while on study. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be >/=15 mm in short axis when assessed by CT scan. The clinical benefit rate was not updated at the final analysis.
Time Frame
Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] months vs. 21.3 [0-39] months)
Title
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03
Description
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. The investigator graded all AEs for severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
Time Frame
From Baseline until end of post-treatment follow-up (up to 70 months)
Title
Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD)
Description
The number and percentage of participants with symptomatic left ventricular systolic dysfunction (LVSD) and asymptomatic LVSD events (defined as a left ventricular ejection fraction [LVEF] ≥10% decrease from baseline to an absolute value <50%) at any time during the study was summarized by treatment arm.
Time Frame
From Baseline until end of post-treatment follow-up (up to 70 months)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
Description
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Time Frame
Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)
Title
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score
Description
The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. A positive value means an increase, while a negative values means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Time Frame
Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)
Title
Maximum Serum Concentration (Cmax) of Pertuzumab
Time Frame
Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)
Title
Cmax of Trastuzumab
Time Frame
Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)
Title
Minimum Serum Concentration (Cmin) of Pertuzumab
Time Frame
Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)
Title
Cmin of Trastuzumab
Time Frame
Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic adenocarcinoma of the stomach or GEJ Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Life expectancy greater than equal to (>/=) 3 months Exclusion Criteria: Previous cytotoxic chemotherapy for advanced (metastatic) disease Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma Previous treatment with any HER2-directed therapy, at any time, for any duration Previous exposure to any investigational treatment within 30 days before the first dose of study treatment Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to bone metastases, if recovered from all toxicities) History or evidence of brain metastases Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0]) Residual toxicity resulting from previous therapy (for example, hematologic, cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted Other malignancy (in addition to gastric cancer [GC]) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent Inadequate hematologic, renal or liver function Pregnant or lactating women History of congestive heart failure of any New York Heart Association (NYHA) criteria Angina pectoris requiring treatment Myocardial infarction within the past 6 months before the first dose of study drug Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia History or evidence of poorly controlled hypertension Baseline left ventricular ejection fraction (LVEF) value less than (<) 55 percent (%) Any significant uncontrolled intercurrent systemic illness Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Florida Cancer Specialists - SCRI; Pharmacy
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University Of Chicago Medical Center; Section Of Hematology/Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Health; Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Eastern Avenue
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Queens Medical Associates
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
Weill Medical College of Cornell University; Division of Hematology & Medical Oncology
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Medical University of South Carolina; Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Oncology PLLC - Nashville (20th Ave)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Royal Brisbane Womens Hosp; Division of Oncology
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Monash Medical Centre; Oncology
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Health; Cancer Clinical Trial Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Sir Charles Gairdner Hospital; Medical Oncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin
City
Zams
ZIP/Postal Code
6511
Country
Austria
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Clinicas Oncologicas Integradas - COI
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
22290-160
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Centro de Pesquisas Oncologicas - CEPON
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Hospital Sirio Libanes; Centro de Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Clinica de Oncologia Medica
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01406100
Country
Brazil
Facility Name
Hospital A. C. Camargo; Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01509-010
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo - UNIFESP*X
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Complex Oncological Center - Plovdiv, EOOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
MHAT Serdika
City
Sofia
ZIP/Postal Code
1301
Country
Bulgaria
Facility Name
SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Hamilton Health Sciences - Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Toronto East General Hospital; Haematology/Oncology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital; Oncology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
McGill University; Glen Site; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences.
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
Changzhou First People's Hospital
City
Changzhou
ZIP/Postal Code
213003
Country
China
Facility Name
Third Affiliated Hospital of Third Military Medical University
City
ChongQing
ZIP/Postal Code
400042
Country
China
Facility Name
Fuzhou General Hospital, PLA Nanjing Military Area Command
City
Fuzhou
ZIP/Postal Code
110016
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
The 1st Affiliated Hospital of Nanchang Unversity
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
The 81st Hospital of P.L.A.
City
Nanjing City
ZIP/Postal Code
210002
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
ZIP/Postal Code
226001
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
General Hospital of Shenyang Military Command of PLA
City
Shenyang
ZIP/Postal Code
110016
Country
China
Facility Name
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
City
Shijiazhuang
ZIP/Postal Code
050035
Country
China
Facility Name
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
City
Xi'an
ZIP/Postal Code
710032
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Sisters of Mercy
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Hospital Oncologia; Oncology
City
Salvador
ZIP/Postal Code
01101
Country
El Salvador
Facility Name
Docrates Cance Center
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Turku Uni Central Hospital; Oncology Clinics
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Ludwigsburg; Studiensekretariat
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Medical Solution; Hematology
City
Guatemala
ZIP/Postal Code
01-010
Country
Guatemala
Facility Name
Semmelweis Egyetem Onkologiai Központ
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Irccs Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedali Riuniti Di Ancona; Oncology
City
Ancona
State/Province
Marche
ZIP/Postal Code
60121
Country
Italy
Facility Name
Ospedale Casa Sollievo Della Sofferenza IRCCS
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
Ospedale Misericordia E Dolce; Oncologia Medica
City
Prato
State/Province
Toscana
ZIP/Postal Code
59100
Country
Italy
Facility Name
Aichi Cancer Center Hospital; Clinical Oncology
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya university Hospital; Gastroenterological Surgery 2
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
National Cancer Center Hospital East; Gastroenterology
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center; Gastroenterology
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Kyushu University Hospital; Surgery and Science
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu University Hospital; Digestive Surgery
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital; Surgery
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Kobe city Medical center General Hospital; Medical Oncology
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
St.Marianna University School of Medicine hospital; Medical Oncology
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kanagawa Cancer Center; Gastrointestinal Surgery
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka General Medical Center; Gastroenterological Surgery
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Saitama Cancer Center; Gastroenterology
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Cancer Center Hospital; Gastrointestinal Oncology
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toyama University Hospital;Gastroenterology and Hematology
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
City
Almaty
ZIP/Postal Code
050022
Country
Kazakhstan
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
(0)6351
Country
Korea, Republic of
Facility Name
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center; Medical Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Universiti Sains Malaysia [Neurology]
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre; Clinical Oncology Unit,
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Wanita dan Kanak-Kanak Sabah
City
Sabah
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Hospital Angeles Metropolitano; Room 220
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Inst. Nacional de Cancerologia; Investigacion Clinica
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Academisch Medisch Centrum Universiteit Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Clinical Hospital; Oncology Department
City
Bitola
ZIP/Postal Code
7000
Country
North Macedonia
Facility Name
University Clinic for Radiotherapy and Oncology
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Medical Research Centre
City
Panama
Country
Panama
Facility Name
Centro Medico Monte Carmelo
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Hospital Sabogal; Oncology
City
Callao
ZIP/Postal Code
02
Country
Peru
Facility Name
Hosp Nacion Edgardo Rebagliati; Oncologia Medica
City
Jesus Maria
ZIP/Postal Code
Lima 11
Country
Peru
Facility Name
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Clinica San Borja
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Facility Name
NZOZ Centrum Medyczne HCP Sp. z o.o.
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny Nr 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Cardiomed Medical Center
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Oncology Center Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Euroclinic Center of Oncology SRL
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary; Chemotherapy
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Duran i Reynals; Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
CHUV; Departement d'Oncologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Luzerner Kantonsspital; Medizinische Onkologie
City
Luzern
ZIP/Postal Code
6004
Country
Switzerland
Facility Name
Taichung Veterans General Hospital; Dept of Surgery
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng Kung University Hospital; Oncology
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Khonkaen Hospital
City
Khonkaen
ZIP/Postal Code
40000
Country
Thailand
Facility Name
Songklanagarind Hospital; Department of Oncology
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Ankara Uni School of Medicine; Medical Oncology
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Akdeniz University Medical Faculty; Medical Oncology Department
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
Facility Name
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Facility Name
TC Necmettin Erbakan University Meram Medical Faculty Hospital
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
36066725
Citation
Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Siddiqui A, Heeson S, Kiermaier A, Macharia H, Restuccia E, Kang YK. Pertuzumab, trastuzumab, and chemotherapy in HER2-positive gastric/gastroesophageal junction cancer: end-of-study analysis of the JACOB phase III randomized clinical trial. Gastric Cancer. 2023 Jan;26(1):123-131. doi: 10.1007/s10120-022-01335-4. Epub 2022 Sep 6.
Results Reference
derived
PubMed Identifier
31234927
Citation
Liu T, Qin Y, Li J, Xu R, Xu J, Yang S, Qin S, Bai Y, Wu C, Mao Y, Wu H, Ge Y, Shen L. Pertuzumab in combination with trastuzumab and chemotherapy for Chinese patients with HER2-positive metastatic gastric or gastroesophageal junction cancer: a subpopulation analysis of the JACOB trial. Cancer Commun (Lond). 2019 Jun 24;39(1):38. doi: 10.1186/s40880-019-0384-6.
Results Reference
derived
PubMed Identifier
31183514
Citation
Kirschbrown WP, Wang B, Nijem I, Ohtsu A, Hoff PM, Shah MA, Shen L, Kang YK, Alsina M, Girish S, Garg A. Pharmacokinetic and exposure-response analysis of pertuzumab in patients with HER2-positive metastatic gastric or gastroesophageal junction cancer. Cancer Chemother Pharmacol. 2019 Sep;84(3):539-550. doi: 10.1007/s00280-019-03871-w. Epub 2019 Jun 10.
Results Reference
derived
PubMed Identifier
30217672
Citation
Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Cheng K, Song C, Wu H, Eng-Wong J, Kim K, Kang YK. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018 Oct;19(10):1372-1384. doi: 10.1016/S1470-2045(18)30481-9. Epub 2018 Sep 11.
Results Reference
derived

Learn more about this trial

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

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