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
NCT ID: NCT01774786
Last Updated: 2020-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
780 participants
INTERVENTIONAL
2013-06-10
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pertuzumab + Trastuzumab + Chemotherapy
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.
5-Fluorouracil
Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m\^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.
Capecitabine
Participants will receive capecitabine 1000 mg/m\^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.
Cisplatin
Participants will receive cisplatin 80 mg/m\^2 IV q3w for 6 cycles.
Pertuzumab
Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Trastuzumab
Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Placebo + Trastuzumab + Chemotherapy
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.
5-Fluorouracil
Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m\^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.
Capecitabine
Participants will receive capecitabine 1000 mg/m\^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.
Cisplatin
Participants will receive cisplatin 80 mg/m\^2 IV q3w for 6 cycles.
Placebo
Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Trastuzumab
Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Interventions
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5-Fluorouracil
Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m\^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.
Capecitabine
Participants will receive capecitabine 1000 mg/m\^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.
Cisplatin
Participants will receive cisplatin 80 mg/m\^2 IV q3w for 6 cycles.
Pertuzumab
Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Placebo
Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Trastuzumab
Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Florida Cancer Specialists - SCRI; Pharmacy
Fort Myers, Florida, United States
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago, Illinois, United States
Indiana University Health; Goshen Center for Cancer Care
Goshen, Indiana, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Queens Medical Associates
Fresh Meadows, New York, United States
Weill Medical College of Cornell University; Division of Hematology & Medical Oncology
New York, New York, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Medical University of South Carolina; Hollings Cancer Center
Charleston, South Carolina, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, United States
Royal Brisbane Womens Hosp; Division of Oncology
Herston, Queensland, Australia
Monash Medical Centre; Oncology
Clayton, Victoria, Australia
Austin Health; Cancer Clinical Trial Centre
Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital; Medical Oncology
Perth, Western Australia, Australia
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, , Austria
Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin
Zams, , Austria
Cliniques Universitaires St-Luc
Brussels, , Belgium
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, Brazil
Hospital Sirio Libanes; Centro de Oncologia
São Paulo, São Paulo, Brazil
Clinica de Oncologia Medica
São Paulo, São Paulo, Brazil
Hospital A. C. Camargo; Oncologia
São Paulo, São Paulo, Brazil
Universidade Federal de Sao Paulo - UNIFESP*X
São Paulo, São Paulo, Brazil
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, , Bulgaria
MHAT Serdika
Sofia, , Bulgaria
SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative
Varna, , Bulgaria
Health Sciences North
Greater Sudbury, Ontario, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Toronto East General Hospital; Haematology/Oncology
Toronto, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Mount Sinai Hospital; Oncology
Toronto, Ontario, Canada
McGill University; Glen Site; Oncology
Montreal, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, , China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
the First Hospital of Jilin University
Changchun, , China
Jilin Cancer Hospital
Changchun, , China
Changzhou First People's Hospital
Changzhou, , China
Third Affiliated Hospital of Third Military Medical University
Chongqing, , China
Fuzhou General Hospital, PLA Nanjing Military Area Command
Fuzhou, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, , China
The 81st Hospital of P.L.A.
Nanjing, , China
Affiliated Hospital of Nantong University
Nantong, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
General Hospital of Shenyang Military Command of PLA
Shenyang, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, , China
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Xi'an, , China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Clinical Hospital Sisters of Mercy
Zagreb, , Croatia
Hospital Oncologia; Oncology
San Salvador, , El Salvador
Docrates Cance Center
Helsinki, , Finland
Turku Uni Central Hospital; Oncology Clinics
Turku, , Finland
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Berlin, , Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen, , Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
Essen, , Germany
Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
Esslingen am Neckar, , Germany
Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum
Hamburg, , Germany
Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)
Leipzig, , Germany
Klinikum Ludwigsburg; Studiensekretariat
Ludwigsburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik
Mainz, , Germany
Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
Mannheim, , Germany
Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
Marburg, , Germany
Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
Ulm, , Germany
Medical Solution; Hematology
Guatemala City, , Guatemala
Semmelweis Egyetem Onkologiai Központ
Budapest, , Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, , Hungary
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
Miskolc, , Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, , Hungary
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Apulia, Italy
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy
AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
Reggio Emilia, Emilia-Romagna, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli Venezia Giulia, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milan, Lombardy, Italy
Ospedali Riuniti Di Ancona; Oncology
Ancona, The Marches, Italy
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
Pisa, Tuscany, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, Italy
Aichi Cancer Center Hospital; Clinical Oncology
Aichi, , Japan
Nagoya university Hospital; Gastroenterological Surgery 2
Aichi, , Japan
National Cancer Center Hospital East; Gastroenterology
Chiba, , Japan
National Hospital Organization Shikoku Cancer Center; Gastroenterology
Ehime, , Japan
Kyushu University Hospital; Surgery and Science
Fukuoka, , Japan
Gifu University Hospital; Digestive Surgery
Gifu, , Japan
Hiroshima City Hiroshima Citizens Hospital; Surgery
Hiroshima, , Japan
Kobe city Medical center General Hospital; Medical Oncology
Hyōgo, , Japan
St.Marianna University School of Medicine hospital; Medical Oncology
Kanagawa, , Japan
Kanagawa Cancer Center; Gastrointestinal Surgery
Kanagawa, , Japan
Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology
Osaka, , Japan
Osaka General Medical Center; Gastroenterological Surgery
Osaka, , Japan
Saitama Cancer Center; Gastroenterology
Saitama, , Japan
National Cancer Center Hospital; Gastrointestinal Oncology
Tokyo, , Japan
Toyama University Hospital;Gastroenterology and Hematology
Toyama, , Japan
Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
Almaty, , Kazakhstan
Hospital Universiti Sains Malaysia [Neurology]
Kubang Kerian, Kelantan, Malaysia
Hospital Wanita dan Kanak-Kanak Sabah
Sabah, Sabah, Malaysia
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
Kuala Lumpur, , Malaysia
University Malaya Medical Centre; Clinical Oncology Unit,
Kuala Lumpur, , Malaysia
Hospital Angeles Metropolitano; Room 220
Mexico City, Mexico CITY (federal District), Mexico
Inst. Nacional de Cancerologia; Investigacion Clinica
Mexico City, , Mexico
Oaxaca Site Management Organization
Oaxaca City, , Mexico
Academisch Medisch Centrum Universiteit Amsterdam
Amsterdam, , Netherlands
Clinical Hospital; Oncology Department
Bitola, , North Macedonia
University Clinic for Radiotherapy and Oncology
Skopje, , North Macedonia
Medical Research Centre
Panama City, , Panama
Centro Medico Monte Carmelo
Arequipa, , Peru
Hospital Sabogal; Oncology
Callao, , Peru
Hosp Nacion Edgardo Rebagliati; Oncologia Medica
Jesus Maria, , Peru
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, , Peru
Clinica San Borja
Lima, , Peru
Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
Bialystok, , Poland
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, , Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, , Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, , Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
Opole, , Poland
NZOZ Centrum Medyczne HCP Sp. z o.o.
Poznan, , Poland
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik, , Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
Warsaw, , Poland
Cardiomed Medical Center
Cluj-Napoca, , Romania
Oncology Center Sf. Nectarie
Craiova, , Romania
Euroclinic Center of Oncology SRL
Iași, , Romania
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', , Russia
Clinical Oncology Dispensary; Chemotherapy
Omsk, , Russia
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
Ryazan, , Russia
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, , Russia
Kyungpook National University Medical Center
Daegu, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, , South Korea
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
Seoul, , South Korea
Asan Medical Center; Medical Oncology
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, , Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, , Spain
Hospital Duran i Reynals; Oncologia
Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
CHUV; Departement d'Oncologie
Lausanne, , Switzerland
Luzerner Kantonsspital; Medizinische Onkologie
Lucerne, , Switzerland
Taichung Veterans General Hospital; Dept of Surgery
Taichung, , Taiwan
National Cheng Kung University Hospital; Oncology
Tainan City, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan District, , Taiwan
Rajavithi Hospital; Division of Medical Oncology
Bangkok, , Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, , Thailand
Khonkaen Hospital
Khonkaen, , Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla, , Thailand
Ankara Uni School of Medicine; Medical Oncology
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, , Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, , Turkey (Türkiye)
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
TC Necmettin Erbakan University Meram Medical Faculty Hospital
Konya, , Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2012-003554-83
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO25114
Identifier Type: -
Identifier Source: org_study_id