Back to resultsA Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer (HELOISE)
Primary Purpose
Gastric Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Cisplatin
Herceptin
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least liver or lung or both
- Measurable disease according to RECIST Version 1.1 or non-measurable evaluable disease
- At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor, where metastasis in distant lymph nodes, peritoneal metastasis, and malignant pleural effusion may count as "organs" in this context
- HER2-positive primary or metastatic tumor as assessed by central laboratory
- Adequate renal function (creatinine clearance greater than equal to (≥) 45 milliliters per minute [mL/min])
- Eastern Cooperative Oncology Group (ECOG) performance status of 2
Exclusion Criteria:
- Previous chemotherapy for locally advanced or metastatic disease
- Prior gastrectomy (partial or total) for the underlying malignant disease under investigation
- Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
- Residual relevant toxicity resulting from previous therapy
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (such as jejunostomy probe and gastric or jejunostomy tubes) which may impair the ability to administer or absorb capecitabine
- Current (significant or uncontrolled) gastrointestinal bleeding
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin
- History of documented congestive heart failure, angina pectoris requiring medication, electrocardiogram (ECG) evidence of transmural myocardial infraction, poorly controlled hypertension, clinically significant valvular heart disease, or high-risk uncontrollable arrhythmias
- Baseline left ventricular ejection fraction (LVEF) less than (<) 50%, documented by echocardiography, multiple-gated radionuclide angiography (MUGA) scan, or cardiac magnetic resonance imaging (MRI)
- Chronic or high-dose corticosteroid therapy
- History or clinical evidence of brain metastases
- Pregnant women
- Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or HIV-seropositive
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Capecitabine + Cisplatin + Herceptin (6 mg/kg)
Capecitabine + Cisplatin + Herceptin (10 mg/kg)
Arm Description
Participants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as a standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Participants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Outcomes
Primary Outcome Measures
Percentage of Participants Who Died - FAS
The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data.
Overall Survival - FAS
Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Secondary Outcome Measures
Percentage of Participants Who Died - Per Protocol Set (PPS)
The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.
Overall Survival - PPS
Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley.
Percentage of Participants With Disease Progression or Death - PPS
Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.
Progression-Free Survival - PPS
Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley.
Percentage of Participants With Objective Response - PPS
Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method.
Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS
Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL.
Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS
Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01450696
Brief Title
A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
Acronym
HELOISE
Official Title
A Randomized, Open Label, Multicenter Phase IIIb Study Comparing Two Trastuzumab Dosing Regimens, Each in Combination With Cisplatin/Capecitabine Chemotherapy, as First-Line Therapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Adenocarcinoma Who Have Not Received Prior Treatment for Metastatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
futility following planned interim analysis
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously as either an 8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per meter-squared (mg/m^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m^2 on Day 1 of each 3-week cycle. Herceptin will be continued until disease progression occurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine + Cisplatin + Herceptin (6 mg/kg)
Arm Type
Active Comparator
Arm Description
Participants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as a standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Arm Title
Capecitabine + Cisplatin + Herceptin (10 mg/kg)
Arm Type
Experimental
Arm Description
Participants will receive Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants will also receive cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine will be administered at a dose of 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 cycles (Cycles 1 to 6).
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin will be administered at a dose of 80 mg/m^2 intravenously q3w on Day 1 of each 3-week cycle for up to 6 cycles (Cycles 1 to 6).
Intervention Type
Drug
Intervention Name(s)
Herceptin
Other Intervention Name(s)
Trastuzumab
Intervention Description
Herceptin will be administered at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 or 10 mg/kg (depending upon treatment assignment) q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Died - FAS
Description
The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data.
Time Frame
From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Title
Overall Survival - FAS
Description
Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Time Frame
From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Died - Per Protocol Set (PPS)
Description
The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.
Time Frame
From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Title
Overall Survival - PPS
Description
Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)
Title
Percentage of Participants With Disease Progression or Death - PPS
Description
Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.
Time Frame
From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)
Title
Progression-Free Survival - PPS
Description
Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)
Title
Percentage of Participants With Objective Response - PPS
Description
Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method.
Time Frame
From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)
Title
Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS
Description
Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL.
Time Frame
Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days)
Title
Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS
Description
Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL.
Time Frame
Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least liver or lung or both
Measurable disease according to RECIST Version 1.1 or non-measurable evaluable disease
At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor, where metastasis in distant lymph nodes, peritoneal metastasis, and malignant pleural effusion may count as "organs" in this context
HER2-positive primary or metastatic tumor as assessed by central laboratory
Adequate renal function (creatinine clearance greater than equal to (≥) 45 milliliters per minute [mL/min])
Eastern Cooperative Oncology Group (ECOG) performance status of 2
Exclusion Criteria:
Previous chemotherapy for locally advanced or metastatic disease
Prior gastrectomy (partial or total) for the underlying malignant disease under investigation
Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
Residual relevant toxicity resulting from previous therapy
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (such as jejunostomy probe and gastric or jejunostomy tubes) which may impair the ability to administer or absorb capecitabine
Current (significant or uncontrolled) gastrointestinal bleeding
Other malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin
History of documented congestive heart failure, angina pectoris requiring medication, electrocardiogram (ECG) evidence of transmural myocardial infraction, poorly controlled hypertension, clinically significant valvular heart disease, or high-risk uncontrollable arrhythmias
Baseline left ventricular ejection fraction (LVEF) less than (<) 50%, documented by echocardiography, multiple-gated radionuclide angiography (MUGA) scan, or cardiac magnetic resonance imaging (MRI)
Chronic or high-dose corticosteroid therapy
History or clinical evidence of brain metastases
Pregnant women
Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or HIV-seropositive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3728
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
City
Sarajewo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
City
Sorocaba
State/Province
SP
ZIP/Postal Code
18030-245
Country
Brazil
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
City
Viña del Mar
ZIP/Postal Code
2520612
Country
Chile
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
100071
Country
China
City
Beijing
ZIP/Postal Code
100142
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Changchun
ZIP/Postal Code
130012
Country
China
City
Changsha
ZIP/Postal Code
410006
Country
China
City
Changzhou
ZIP/Postal Code
213003
Country
China
City
Guangzhou
ZIP/Postal Code
510060
Country
China
City
Hangzhou
ZIP/Postal Code
310016
Country
China
City
Nanjing
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Wuhan
ZIP/Postal Code
430030
Country
China
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
City
Ancona
State/Province
Marche
ZIP/Postal Code
60121
Country
Italy
City
Florence
State/Province
Toscana
ZIP/Postal Code
50124
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
City
Bundang City
ZIP/Postal Code
463-802
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
City
Mexico City
ZIP/Postal Code
06760
Country
Mexico
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Panama
ZIP/Postal Code
0834-02723
Country
Panama
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
City
Arequipa
ZIP/Postal Code
5154
Country
Peru
City
Lima
ZIP/Postal Code
1
Country
Peru
City
Lima
ZIP/Postal Code
34
Country
Peru
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
City
Trujillo
ZIP/Postal Code
13011
Country
Peru
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Warsaw
ZIP/Postal Code
00-973
Country
Poland
City
Wieliszew
ZIP/Postal Code
05-135
Country
Poland
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Stavropol
ZIP/Postal Code
355045
Country
Russian Federation
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
City
Cape Town
ZIP/Postal Code
7506
Country
South Africa
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Adana
ZIP/Postal Code
01250
Country
Turkey
City
Gaziantep
ZIP/Postal Code
27100
Country
Turkey
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
City
Sıhhiye, ANKARA
ZIP/Postal Code
06100
Country
Turkey
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
City
Lvov
ZIP/Postal Code
79031
Country
Ukraine
City
Denbighshire
ZIP/Postal Code
LL185UJ
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
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