Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Survival
timeFrame: 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 outcomes:
measure: Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria
timeFrame: 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)
measure: Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
timeFrame: 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)
measure: Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
timeFrame: 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)
measure: Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria
timeFrame: 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)
measure: Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria
timeFrame: 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)
measure: 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
timeFrame: From Baseline until end of post-treatment follow-up (up to 70 months)
measure: Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD)
timeFrame: From Baseline until end of post-treatment follow-up (up to 70 months)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
timeFrame: 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)
measure: Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score
timeFrame: 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)
measure: Maximum Serum Concentration (Cmax) of Pertuzumab
timeFrame: 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)
measure: Cmax of Trastuzumab
timeFrame: 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)
measure: Minimum Serum Concentration (Cmin) of Pertuzumab
timeFrame: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)
measure: Cmin of Trastuzumab
timeFrame: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - SCRI; Pharmacy
state: Florida
city: Chicago
country: United States
facility: University Of Chicago Medical Center; Section Of Hematology/Oncology
state: Illinois
city: Goshen
country: United States
facility: Indiana University Health; Goshen Center for Cancer Care
state: Indiana
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Fresh Meadows
country: United States
facility: Queens Medical Associates
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University; Division of Hematology & Medical Oncology
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina; Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology PLLC - Nashville (20th Ave)
state: Tennessee
city: Herston
country: Australia
facility: Royal Brisbane Womens Hosp; Division of Oncology
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre; Oncology
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health; Cancer Clinical Trial Centre
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital; Medical Oncology
state: Western Australia
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Zams
country: Austria
facility: Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Rio De Janeiro
country: Brazil
facility: Clinicas Oncologicas Integradas - COI
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas - CEPON
state: SC
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes; Centro de Oncologia
state: SP
city: Sao Paulo
country: Brazil
facility: Clinica de Oncologia Medica
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital A. C. Camargo; Oncologia
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP*X
state: SP
city: Plovdiv
country: Bulgaria
facility: Complex Oncological Center - Plovdiv, EOOD
city: Sofia
country: Bulgaria
facility: MHAT Serdika
city: Varna
country: Bulgaria
facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital; Haematology/Oncology
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital; Oncology
state: Ontario
city: Montreal
country: Canada
facility: McGill University; Glen Site; Oncology
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changzhou
country: China
facility: Changzhou First People's Hospital
city: ChongQing
country: China
facility: Third Affiliated Hospital of Third Military Medical University
city: Fuzhou
country: China
facility: Fuzhou General Hospital, PLA Nanjing Military Area Command
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanchang
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Nanjing City
country: China
facility: The 81st Hospital of P.L.A.
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Command of PLA
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
city: Xi'an
country: China
facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sisters of Mercy
city: Salvador
country: El Salvador
facility: Hospital Oncologia; Oncology
city: Helsinki
country: Finland
facility: Docrates Cance Center
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Oncology Clinics
city: Berlin
country: Germany
facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
city: Esslingen
country: Germany
facility: Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg; Studiensekretariat
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
city: Marburg
country: Germany
facility: Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
city: Guatemala
country: Guatemala
facility: Medical Solution; Hematology
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Onkologiai Központ
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Napoli
country: Italy
facility: Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
state: Emilia-Romagna
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
state: Lombardia
city: Ancona
country: Italy
facility: Ospedali Riuniti Di Ancona; Oncology
state: Marche
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza IRCCS
state: Puglia
city: Pisa
country: Italy
facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
state: Toscana
city: Prato
country: Italy
facility: Ospedale Misericordia E Dolce; Oncologia Medica
state: Toscana
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital; Clinical Oncology
city: Aichi
country: Japan
facility: Nagoya university Hospital; Gastroenterological Surgery 2
city: Chiba
country: Japan
facility: National Cancer Center Hospital East; Gastroenterology
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center; Gastroenterology
city: Fukuoka
country: Japan
facility: Kyushu University Hospital; Surgery and Science
city: Gifu
country: Japan
facility: Gifu University Hospital; Digestive Surgery
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital; Surgery
city: Hyogo
country: Japan
facility: Kobe city Medical center General Hospital; Medical Oncology
city: Kanagawa
country: Japan
facility: St.Marianna University School of Medicine hospital; Medical Oncology
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center; Gastrointestinal Surgery
city: Osaka
country: Japan
facility: Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology
city: Osaka
country: Japan
facility: Osaka General Medical Center; Gastroenterological Surgery
city: Saitama
country: Japan
facility: Saitama Cancer Center; Gastroenterology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Gastrointestinal Oncology
city: Toyama
country: Japan
facility: Toyama University Hospital;Gastroenterology and Hematology
city: Almaty
country: Kazakhstan
facility: Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia [Neurology]
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre; Clinical Oncology Unit,
city: Sabah
country: Malaysia
facility: Hospital Wanita dan Kanak-Kanak Sabah
city: Mexico City
country: Mexico
facility: Hospital Angeles Metropolitano; Room 220
state: Mexico CITY (federal District)
city: Mexico City
country: Mexico
facility: Inst. Nacional de Cancerologia; Investigacion Clinica
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit Amsterdam
city: Bitola
country: North Macedonia
facility: Clinical Hospital; Oncology Department
city: Skopje
country: North Macedonia
facility: University Clinic for Radiotherapy and Oncology
city: Panama
country: Panama
facility: Medical Research Centre
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Callao
country: Peru
facility: Hospital Sabogal; Oncology
city: Jesus Maria
country: Peru
facility: Hosp Nacion Edgardo Rebagliati; Oncologia Medica
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
city: Lima
country: Peru
facility: Clinica San Borja
city: Bialystok
country: Poland
facility: Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
city: Opole
country: Poland
facility: SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
city: Poznan
country: Poland
facility: NZOZ Centrum Medyczne HCP Sp. z o.o.
city: Rybnik
country: Poland
facility: Wojewódzki Szpital Specjalistyczny Nr 3
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
city: Cluj-Napoca
country: Romania
facility: Cardiomed Medical Center
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: Iasi
country: Romania
facility: Euroclinic Center of Oncology SRL
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary; Chemotherapy
city: Ryazan
country: Russian Federation
facility: SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
city: Samara
country: Russian Federation
facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Oncologia
state: Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Lausanne
country: Switzerland
facility: CHUV; Departement d'Oncologie
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital; Medizinische Onkologie
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Dept of Surgery
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital; Oncology
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Dept of Oncology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
city: Bangkok
country: Thailand
facility: Rajavithi Hospital; Division of Medical Oncology
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Khonkaen
country: Thailand
facility: Khonkaen Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Department of Oncology
city: Ankara
country: Turkey
facility: Ankara Uni School of Medicine; Medical Oncology
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty; Medical Oncology Department
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
city: Erzurum
country: Turkey
facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Konya
country: Turkey
facility: TC Necmettin Erbakan University Meram Medical Faculty Hospital
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.