Clinical trial NCT01641939: A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
Official title: A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 415
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 multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square \[mg/m\^2\] IV every 3 weeks or paclitaxel 80 mg/m\^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.

Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 12 weeks from the first dose of study treatment
* Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
* Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization
* Participants must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease
* HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)
* Participants must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy.
* First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy.
* Adjuvant or neoadjuvant therapy for AGC is allowed.

Exclusion Criteria:

* An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
* Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen.
* Treatment with any investigational anticancer drug within 21 days of the first study treatment administration
* More than one prior line of therapy for advanced gastric cancer
* History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
* Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization
* Peripheral neuropathy Grade \>/=2
* Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia)
* Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)
* Clinically significant bleeding within 30 days before enrollment
* For female participants, current pregnancy or lactation
* Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
* Infection with Human immunodeficiency virus (HIV) or hepatitis B virus, hepatitis C virus

Primary outcomes:
measure: Overall Survival (OS)- Phase 3
timeFrame: Date of randomization until death (up to 2 years 3 months)
measure: Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)
timeFrame: Date of randomization until death (up to 1 year)
Secondary outcomes:
measure: Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3
timeFrame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
measure: Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3
timeFrame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
measure: Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3
timeFrame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
measure: Duration of Objective Response (DOR) - Phase 3
timeFrame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)
measure: Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3
timeFrame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)
measure: Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3
timeFrame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)
measure: Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3
timeFrame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)
measure: Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3
timeFrame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)
measure: Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1
timeFrame: Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)
measure: Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1
timeFrame: C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)
measure: Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2
timeFrame: C1D1; C4D1
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1
timeFrame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)
measure: Plasma Decay Half-Life (t1/2) - Stage 1
timeFrame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)
measure: Volume of Distribution at Steady State (Vss) - Stage 1
timeFrame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)
measure: Systemic Clearance (CL) - Stage 1
timeFrame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood/Cancer Ctr
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Westwood
country: United States
facility: University of Kansas; Medical Center & Medical pavilion
state: Kansas
city: Louisville
country: United States
facility: Norton Healthcare Inc.
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital.
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Can Ins
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Buenos Aires
country: Argentina
facility: Fundación Investigar
city: Buenos Aires
country: Argentina
facility: Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Oncologia
state: RJ
city: Porto Alegre
country: Brazil
facility: Clinica de Oncologia de Porto Alegre - CliniOnco
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba - CEPOS
state: SP
city: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
state: British Columbia
city: Brampton
country: Canada
facility: Brampton Memorial Hospital, William Osler Health Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital; Haematology/Oncology
state: Ontario
city: Toronto
country: Canada
facility: St. Michael'S Hospital
state: Ontario
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: Jilin Cancer Hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
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: Fujian Cancer Hospital
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: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
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: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Command of PLA
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
city: Praha 5
country: Czechia
facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept of Oncology
city: Brest
country: France
facility: Hopital Augustin Morvan; Federation De Cancerologie
city: Clichy
country: France
facility: Hopital Beaujon; Gastro Enterologie 1
city: Montpellier
country: France
facility: Centre Val Aurelle Paul Lamarque; Medecine A1 A2
city: Paris
country: France
facility: Hopital Saint Antoine; Hepatologie-Gastr-Enterologie
city: Paris
country: France
facility: Hop Europeen Georges Pompidou; Gastro Enterologie
city: Reims
country: France
facility: Hopital Robert Debre; Gastro Enterologie
city: Toulouse
country: France
facility: Hopital Purpan; Unite Onco Digestive
city: Berlin
country: Germany
facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf, Studien GbR
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Landshut
country: Germany
facility: Tagesklinik Landshut; Hämatologie/Onkologie
city: Magdeburg
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Guatemala
country: Guatemala
facility: Centro Oncológico Sixtino / Centro Oncológico SA
city: Budapest
country: Hungary
facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Szolnok
country: Hungary
facility: Hetenyi Geza County Hospital; Onkologiai Kozpont
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály
city: Catanzaro
country: Italy
facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella
state: Calabria
city: Bologna
country: Italy
facility: AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica
state: Emilia-Romagna
city: Torino
country: Italy
facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
state: Piemonte
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
state: Toscana
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana; Oncologia
state: Toscana
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital; Clinical Oncology
city: Chiba
country: Japan
facility: Chiba Cancer Center; Gastroenterology
city: Chiba
country: Japan
facility: National Cancer Center Hospital East; Gastroenterology
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center; Gastroenterology
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital：Gastroenterology
city: Hyogo
country: Japan
facility: Hyogo College Of Medicine; Upper Gastroenterology
city: Hyogo
country: Japan
facility: Hyogo Cancer Center; Gastroenterology
city: Ibaraki
country: Japan
facility: Ibaraki Prefectural Central Hospital; Gastroenterology
city: Miyagi
country: Japan
facility: Tohoku Uni Hospital; Clinical Oncology
city: Osaka
country: Japan
facility: Osaka University Hospital; Surgery
city: Osaka
country: Japan
facility: Kindai University Hospital; Medical Oncology
city: Saitama
country: Japan
facility: Saitama Cancer Center; Gastroenterology
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center; Gastroenterology
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital; Clinical Oncology
city: Tochigi
country: Japan
facility: Tochigi Cancer Center; Medical Oncology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Gastrointestinal Oncology
city: Tokyo
country: Japan
facility: Toranomon Hospital; Medical Oncology
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital; Chemotherapy
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital, JFCR; Gastroenterology
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital; Oncology Haemotology
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital; Medical Oncology
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: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Chihuahua
country: Mexico
facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
city: Mexico DF
country: Mexico
facility: Hospital General de México; Unidad de Oncologia
city: Panama City
country: Panama
facility: Centro Hemato Oncologico Paitilla
city: Chiclayo
country: Peru
facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco
city: Jesus Maria
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Cebu
country: Philippines
facility: Perpetual Succour Hospital
city: Quezon City, Luzon
country: Philippines
facility: Veterans Memorial Medical Ctr; Cancer Research Centre
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie
city: Rybnik
country: Poland
facility: Wojewódzki Szpital Specjalistyczny Nr 3
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni Bucuresti
city: Cluj-Napoca
country: Romania
facility: Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean Mures; Oncologie Medicala
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Omsk
country: Russian Federation
facility: Omsk Region Clinical Oncology Dispensary; 1St Sergical Department
city: Pyatigorsk
country: Russian Federation
facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
city: Tula
country: Russian Federation
facility: Tula Regional Oncology Dispensary
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Oncologia
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
state: La Coruña
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial; Servicio de Farmacia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Kaohsung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc
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: Erzurum
country: Turkey
facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Istanbul Bilim University School Of Medicine; Department Of Medical Oncology
city: Istanbul
country: Turkey
facility: Marmara Uni Faculty of Medicine; Medical Oncology
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty; Oncology Dept
city: Sıhhiye, ANKARA
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre; Oncology Dept
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
city: London
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Med-Onc
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
city: Weston Super Mare
country: United Kingdom
facility: BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Shah MA, Kang YK, Thuss-Patience PC, Ohtsu A, Ajani JA, Van Cutsem E, Hoersch S, Harle-Yge ML, de Haas SL. Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer. Gastric Cancer. 2019 Jul;22(4):803-816. doi: 10.1007/s10120-018-00923-7. Epub 2019 Jan 31.
citation: Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.