A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

• ClinicalTrials.gov Identifier: NCT01641939
• Recruitment Status: Terminated
• First Posted: July 17, 2012
• Results First Posted: August 11, 2016
• Last Update Posted: May 12, 2017
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Drug: Taxane; Drug: trastuzumab emtansine	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 415 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 3, 2012
• Actual Primary Completion Date: June 30, 2015
• Actual Study Completion Date: April 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard taxane therapy; Docetaxel will be administered at 75 milligram per meter square (mg/m^2) intravenous (IV) on Day 1 of a 21-day cycle, or paclitaxel will administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) according to investigator choice until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.	Drug: Taxane; Standard taxane (docetaxel 75 mg/m^2 IV every 3 weeks or paclitaxel 80 mg/m^2) IV once a week according to investigator choice.
Experimental: trastuzumab emtansine 2.4 mg; Trastuzumab emtansine will be administered on Day 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.	Drug: trastuzumab emtansine; trastuzumab emtansine 2.4 mg/kg IV once a week
Experimental: trastuzumab emtansine 3.6 mg; Trastuzumab emtansine will be administered on Day 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.	Drug: trastuzumab emtansine; trastuzumab emtansine 3.6 mg/kg IV every 3 weeks

Outcome Measures

Primary Outcome Measures :

1. Overall Survival (OS)- Phase 3 [ Time Frame: Date of randomization until death (up to 2 years 3 months) ]
   Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).
2. Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) [ Time Frame: Date of randomization until death (up to 1 year) ]
   Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive.

Secondary Outcome Measures :

1. Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3 [ Time Frame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) ]
   Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
2. Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3 [ Time Frame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) ]
   Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).
3. Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3 [ Time Frame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) ]
   Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
4. Duration of Objective Response (DOR) - Phase 3 [ Time Frame: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) ]
   DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
5. 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 [ Time Frame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months) ]
   The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 'Not at all' to 4 'Very much'; with the exception of the QoL/health status scale which uses a 7-point scale (1 'very poor' to 7 'Excellent'). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
6. Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 [ Time Frame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) ]
   The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 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. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
7. Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3 [ Time Frame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) ]
   AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
8. Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3 [ Time Frame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) ]
   Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
9. Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1 [ Time Frame: Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
   Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization.
10. Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1 [ Time Frame: C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.
11. Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2 [ Time Frame: C1D1; C4D1 ]
    Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015.
12. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.
13. Plasma Decay Half-Life (t1/2) - Stage 1 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.
14. Volume of Distribution at Steady State (Vss) - Stage 1 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.
15. Systemic Clearance (CL) - Stage 1 [ Time Frame: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Comprehensive Blood/Cancer Ctr

Bakersfield, California, United States, 93309

Stanford University School of Medicine

Stanford, California, United States, 94305-5151

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06520

United States, Kansas

University of Kansas; Medical Center & Medical pavilion

Westwood, Kansas, United States, 66205

United States, Kentucky

Norton Healthcare Inc.

Louisville, Kentucky, United States, 40202

United States, Massachusetts

Massachusetts General Hospital.

Boston, Massachusetts, United States, 02114

Dana Farber Can Ins

Boston, Massachusetts, United States, 02215

United States, New York

Weill Cornell Medical College

New York, New York, United States, 10065

United States, Tennessee

Vanderbilt

Nashville, Tennessee, United States, 37232

United States, Texas

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Argentina

Fundación Investigar

Buenos Aires, Argentina, 1025

Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

Buenos Aires, Argentina, C1264AAA

Instituto de Oncología de Rosario

Rosario, Argentina, S2000KZE

Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Brazil

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, RJ, Brazil, 20560-120

Clinica de Oncologia de Porto Alegre - CliniOnco

Porto Alegre, RS, Brazil, 90430-090

Hospital Sao Lucas - PUCRS

Porto Alegre, RS, Brazil, 90610-000

Hospital de Cancer de Barretos

Barretos, SP, Brazil, 14784-400

Hospital Amaral Carvalho

Jau, SP, Brazil, 17210-080

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, SP, Brazil, 01246-000

Instituto de Oncologia de Sorocaba - CEPOS

Sorocaba, SP, Brazil, 18030-245

Canada, British Columbia

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

Brampton Memorial Hospital, William Osler Health Center

Brampton, Ontario, Canada, L6R 3J7

Toronto East General Hospital; Haematology/Oncology

Toronto, Ontario, Canada, M4C 3E7

St. Michael'S Hospital

Toronto, Ontario, Canada, M5B 1W8

China

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

Beijing, China, 100071

Beijing Cancer Hospital

Beijing, China, 100142

Jilin Cancer Hospital

Changchun, China, 130012

the First Hospital of Jilin University

Changchun, China, 130021

Changzhou First People's Hospital

Changzhou, China, 213003

Third Affiliated Hospital of Third Military Medical University

ChongQing, China, 400042

Fujian Cancer Hospital

Fuzhou, China, 350014

Sun Yet-sen University Cancer Center

Guangzhou, China, 510060

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

Hangzhou, China, 310016

Harbin Medical University Cancer Hospital

Harbin, China, 150081

Jiangsu Cancer Hospital

Nanjing, China, 210009

The 81st Hospital of P.L.A.

Nanjing, China

Affiliated Hospital of Nantong University

Nantong, China, 226001

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Zhongshan Hospital Fudan University

Shanghai, China, 200032

Shanghai First People's Hospital

Shanghai, China, 200080

General Hospital of Shenyang Military Command of PLA

Shenyang, China, 110016

Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

Wuhan, China, 430023

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, China, 710061

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, China, 221004

Czechia

Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

Hradec Kralove, Czechia, 500 05

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, Czechia, 779 00

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

Praha 2, Czechia, 128 08

Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

Praha 5, Czechia, 150 06

Finland

Tampere University Hospital; Dept of Oncology

Tampere, Finland, 33520

France

Hopital Augustin Morvan; Federation De Cancerologie

Brest, France, 29200

Hopital Beaujon; Gastro Enterologie 1

Clichy, France, 92118

Centre Val Aurelle Paul Lamarque; Medecine A1 A2

Montpellier, France, 34298

Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

Paris, France, 75571

Hop Europeen Georges Pompidou; Gastro Enterologie

Paris, France, 75908

Hopital Robert Debre; Gastro Enterologie

Reims, France, 51092

Hopital Purpan; Unite Onco Digestive

Toulouse, France, 31059

Germany

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

Berlin, Germany, 10117

Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie

Dresden, Germany, 01307

Facharztzentrum Eppendorf, Studien GbR

Hamburg, Germany, 20249

Universitätsklinikum Köln

Köln, Germany, 50937

Tagesklinik Landshut; Hämatologie/Onkologie

Landshut, Germany, 84028

Onkologische Gemeinschaftspraxis

Magdeburg, Germany, 39104

Guatemala

Grupo Angeles

Guatemala City, Guatemala, 01015

Centro Oncológico Sixtino / Centro Oncológico SA

Guatemala, Guatemala, 01010

Hungary

Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

Budapest, Hungary, 1097

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

Szeged, Hungary, 6720

Hetenyi Geza County Hospital; Onkologiai Kozpont

Szolnok, Hungary, 5004

Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály

Zalaegerszeg, Hungary, 8900

Italy

Campus Universitario S.Venuta; Centro Oncologico T.Campanella

Catanzaro, Calabria, Italy, 88100

AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica

Bologna, Emilia-Romagna, Italy, 40138

A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

Torino, Piemonte, Italy, 10126

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Firenze, Toscana, Italy, 50139

A.O. Universitaria Pisana; Oncologia

Pisa, Toscana, Italy, 56100

Japan

Aichi Cancer Center Hospital; Clinical Oncology

Aichi, Japan, 464-8681

Chiba Cancer Center; Gastroenterology

Chiba, Japan, 260-8717

National Cancer Center Hospital East; Gastroenterology

Chiba, Japan, 277-8577

National Hospital Organization Shikoku Cancer Center; Gastroenterology

Ehime, Japan, 791-0280

Hokkaido University Hospital：Gastroenterology

Hokkaido, Japan, 060-8648

Hyogo College Of Medicine; Upper Gastroenterology

Hyogo, Japan, 663-8501

Hyogo Cancer Center; Gastroenterology

Hyogo, Japan, 673-8558

Ibaraki Prefectural Central Hospital; Gastroenterology

Ibaraki, Japan, 309-1793

Tohoku Uni Hospital; Clinical Oncology

Miyagi, Japan, 980-8574

Osaka University Hospital; Surgery

Osaka, Japan, 565-0871

Kindai University Hospital; Medical Oncology

Osaka, Japan, 589-8511

Saitama Cancer Center; Gastroenterology

Saitama, Japan, 362-0806

Shizuoka Cancer Center; Gastroenterology

Shizuoka, Japan, 411-8777

Shizuoka General Hospital; Clinical Oncology

Shizuoka, Japan, 420-8527

Tochigi Cancer Center; Medical Oncology

Tochigi, Japan, 320-0834

National Cancer Center Hospital; Gastrointestinal Oncology

Tokyo, Japan, 104-0045

Toranomon Hospital; Medical Oncology

Tokyo, Japan, 105-8470

Tokyo Metropolitan Komagome Hospital; Chemotherapy

Tokyo, Japan, 113-8677

The Cancer Institute Hospital, JFCR; Gastroenterology

Tokyo, Japan, 135-8550

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Asan Medical Center; Medical Oncology

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Yonsei University Severance Hospital; Medical Oncology

Seoul, Korea, Republic of, 120-752

Korea University Anam Hospital; Oncology Haemotology

Seoul, Korea, Republic of, 136-705

Seoul St.Mary's Hospital; Medical Oncology

Seoul, Korea, Republic of, 137-807

Malaysia

University Malaya Medical Centre; Clinical Oncology Unit,

Kuala Lumpur, Malaysia, 59100

Hospital Wanita dan Kanak-Kanak Sabah

Sabah, Malaysia, 88996

Mexico

Centenario Hospital Miguel Hidalgo

Aguascalientes, Mexico, 20230

Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

Chihuahua, Mexico, 31000

Hospital General de México; Unidad de Oncologia

Mexico DF, Mexico, 06726

Panama

Centro Hemato Oncologico Paitilla

Panama City, Panama, 083200752

Peru

Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

Chiclayo, Peru, CIX

Hospital Nacional Adolfo Guevara Velasco

Cusco, Peru, 08006

Hospital Nacional Edgardo Rebagliati Martins

Jesus Maria, Peru, Lima 11

Instituto Nacional de Enfermedades Neoplasicas

Lima, Peru, 34

Philippines

Perpetual Succour Hospital

Cebu, Philippines, 6000

Veterans Memorial Medical Ctr; Cancer Research Centre

Quezon City, Luzon, Philippines, 1101

Poland

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, Poland, 80-952

Szpital Uniwersytecki w Krakowie

Krakow, Poland, 31-501

Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

Poznan, Poland, 61-866

Wojewódzki Szpital Specjalistyczny Nr 3

Rybnik, Poland, 44-200

Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

Warszawa, Poland, 02-781

Romania

Institutul Clinic Fundeni Bucuresti

Bucharest, Romania, 022328

Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie

Cluj-Napoca, Romania, 400015

Medisprof SRL

Cluj-Napoca, Romania, 400058

Spitalul Clinic Judetean Mures; Oncologie Medicala

Targu Mures, Romania, 540141

Russian Federation

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Russian Federation, 163045

Ivanovo Regional Oncology Dispensary

Ivanovo, Russian Federation, 153040

Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

Omsk, Russian Federation, 644013

State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

Pyatigorsk, Russian Federation, 357502

Tula Regional Oncology Dispensary

Tula, Russian Federation, 300053

Singapore

National Cancer Centre

Singapore, Singapore, 169610

Spain

Hospital Univ. Central de Asturias; Servicio de Oncologia

Oviedo, Asturias, Spain, 33011

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain, 39008

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, La Coruña, Spain, 15706

Hospital Clinic i Provincial; Servicio de Farmacia

Barcelona, Spain, 08036

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, Spain, 28007

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, Spain, 28046

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla, Spain, 41013

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, Spain, 50009

Taiwan

Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc

Kaohsung, Taiwan, 883

National Taiwan Uni Hospital; Dept of Oncology

Taipei, Taiwan, 100

Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

Taoyuan, Taiwan, 333

Turkey

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

Erzurum, Turkey, 25240

Istanbul Bilim University School Of Medicine; Department Of Medical Oncology

Istanbul, Turkey, 34300

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, Turkey, 34890

Ege Uni Medical Faculty; Oncology Dept

Izmir, Turkey, 35100

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, ANKARA, Turkey, 06100

United Kingdom

Velindre Cancer Centre; Oncology Dept

Cardiff, United Kingdom, CF14 2TL

The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

Glasgow, United Kingdom, G12 0YN

Royal Marsden Hospital; Dept of Med-Onc

London, United Kingdom, SW3 6JJ

Christie Hospital Nhs Trust; Medical Oncology

Manchester, United Kingdom, M2O 4BX

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, United Kingdom, SM2 5PT

BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

Weston Super Mare, United Kingdom, BS23 4TQ

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01641939
• Other Study ID Numbers: BO27952; 2012-000660-22 ( EudraCT Number )
• First Posted: July 17, 2012
• Results First Posted: August 11, 2016
• Last Update Posted: May 12, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Trastuzumab; Ado-Trastuzumab Emtansine; Maytansine; Taxane; Antineoplastic Agents, Immunological; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Immunotoxins; Immunoconjugates; Immunologic Factors; Physiological Effects of Drugs