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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01120184




Registration number
NCT01120184
Ethics application status
Date submitted
28/04/2010
Date registered
10/05/2010
Date last updated
4/03/2024

Titles & IDs
Public title
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
Scientific title
A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
2009-017905-13
Secondary ID [2] 0 0
BO22589
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - docetaxel
Treatment: Drugs - paclitaxel
Treatment: Drugs - pertuzumab
Treatment: Drugs - pertuzumab-placebo
Treatment: Drugs - trastuzumab [Herceptin]
Treatment: Drugs - trastuzumab emtansine

Experimental: Trastuzumab + Taxane (docetaxel or paclitaxel) -

Experimental: Trastuzumab emtansine + pertuzumab -

Experimental: Trastuzumab emtansine + pertuzumab placebo -


Treatment: Drugs: docetaxel
75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.

Treatment: Drugs: paclitaxel
80 mg/m2 intravenously weekly for a minimum of 18 weeks

Treatment: Drugs: pertuzumab
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles

Treatment: Drugs: pertuzumab-placebo
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles

Treatment: Drugs: trastuzumab [Herceptin]
trastuzumab \[Herceptin\] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.

Treatment: Drugs: trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
Timepoint [1] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Primary outcome [2] 0 0
Progression-Free Survival (PFS) According to IRF Assessment
Timepoint [2] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [1] 0 0
Percentage of Participants Who Died Prior to Clinical Cutoff
Timepoint [1] 0 0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Secondary outcome [2] 0 0
Overall Survival (OS) at Clinical Cutoff
Timepoint [2] 0 0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Secondary outcome [3] 0 0
Percentage of Participants With Death or Disease Progression According to Investigator Assessment
Timepoint [3] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [4] 0 0
PFS According to Investigator Assessment
Timepoint [4] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Treatment Failure
Timepoint [5] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [6] 0 0
Time to Treatment Failure (TTF)
Timepoint [6] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [7] 0 0
One-Year Survival Rate
Timepoint [7] 0 0
From randomization until 1 year
Secondary outcome [8] 0 0
Percentage of Participants With Grade =3 Adverse Events
Timepoint [8] 0 0
Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose
Secondary outcome [9] 0 0
Percentage of Participants Who Died at 2 Years
Timepoint [9] 0 0
From randomization until 2 years
Secondary outcome [10] 0 0
Overall Survival Truncated at 2 Years
Timepoint [10] 0 0
From randomization until 2 years
Secondary outcome [11] 0 0
Percentage of Participants With Grade 5 Adverse Events
Timepoint [11] 0 0
Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose)
Secondary outcome [12] 0 0
Percentage of Participants With Grade 3-4 Laboratory Parameters
Timepoint [12] 0 0
Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [13] 0 0
Percentage of Participants With Decline of =2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [13] 0 0
Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months)
Secondary outcome [14] 0 0
Hospitalization Days
Timepoint [14] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [15] 0 0
Percentage of Participants With Hospitalization
Timepoint [15] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [16] 0 0
Percentage of Participants With Objective Response According to IRF Assessment
Timepoint [16] 0 0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [17] 0 0
Percentage of Participants With Objective Response According to Investigator Assessment
Timepoint [17] 0 0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [18] 0 0
Duration of Response According to IRF Assessment
Timepoint [18] 0 0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [19] 0 0
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment
Timepoint [19] 0 0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [20] 0 0
Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score
Timepoint [20] 0 0
Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
Secondary outcome [21] 0 0
Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module
Timepoint [21] 0 0
At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
Secondary outcome [22] 0 0
Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
Timepoint [22] 0 0
At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
Secondary outcome [23] 0 0
Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score
Timepoint [23] 0 0
Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
Secondary outcome [24] 0 0
Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score
Timepoint [24] 0 0
Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014
Secondary outcome [25] 0 0
Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score
Timepoint [25] 0 0
Baseline, Cycle 7 (Week 18)
Secondary outcome [26] 0 0
Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
Timepoint [26] 0 0
Baseline, Cycle 7 (Week 18)
Secondary outcome [27] 0 0
Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
Timepoint [27] 0 0
Baseline, Cycle 7 (Week 18)
Secondary outcome [28] 0 0
Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels
Timepoint [28] 0 0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [29] 0 0
Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels
Timepoint [29] 0 0
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [30] 0 0
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels
Timepoint [30] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [31] 0 0
PFS According to IRF Assessment Among Those With High HER2 mRNA Levels
Timepoint [31] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [32] 0 0
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels
Timepoint [32] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [33] 0 0
PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels
Timepoint [33] 0 0
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary outcome [34] 0 0
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels
Timepoint [34] 0 0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Secondary outcome [35] 0 0
OS at Clinical Cutoff Among Those With High HER2 mRNA Levels
Timepoint [35] 0 0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Secondary outcome [36] 0 0
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels
Timepoint [36] 0 0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Secondary outcome [37] 0 0
OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels
Timepoint [37] 0 0
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)

Eligibility
Key inclusion criteria
* Adult participants >/=18 years of age
* HER2-positive breast cancer
* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
* Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Adequate organ function as determined by laboratory results
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
* An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
* Hormone therapy <7 days prior to randomization
* Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization
* Prior trastuzumab emtansine or pertuzumab therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/09/2016
Sample size
Target
Accrual to date
Final
1095
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Hospital; Chemotherapy Cottage - Sydney
Recruitment hospital [2] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [3] 0 0
Wesley Medical Centre; Clinic For Haematology and Oncology - Auchenflower
Recruitment hospital [4] 0 0
Royal Adelaide Hospital; Oncology - Adelaide
Recruitment hospital [5] 0 0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
2060 - Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
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New Hampshire
Country [18] 0 0
United States of America
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New Jersey
Country [19] 0 0
United States of America
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New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
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North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
North Dakota
Country [23] 0 0
United States of America
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Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
South Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
San Miguel de Tucuman
Country [33] 0 0
Austria
State/province [33] 0 0
Salzburg
Country [34] 0 0
Austria
State/province [34] 0 0
Wien
Country [35] 0 0
Bahamas
State/province [35] 0 0
Nassau
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Namur
Country [38] 0 0
Belgium
State/province [38] 0 0
Wilrijk
Country [39] 0 0
Bosnia and Herzegovina
State/province [39] 0 0
Banja Luka
Country [40] 0 0
Bosnia and Herzegovina
State/province [40] 0 0
Sarajevo
Country [41] 0 0
Brazil
State/province [41] 0 0
RJ
Country [42] 0 0
Brazil
State/province [42] 0 0
RN
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Brazil
State/province [43] 0 0
RS
Country [44] 0 0
Brazil
State/province [44] 0 0
SC
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Brazil
State/province [45] 0 0
SP
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Colombia
State/province [49] 0 0
Bogota
Country [50] 0 0
Colombia
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Bucaramanga
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Colombia
State/province [51] 0 0
Cali
Country [52] 0 0
Colombia
State/province [52] 0 0
Pasto
Country [53] 0 0
Czechia
State/province [53] 0 0
Brno
Country [54] 0 0
Czechia
State/province [54] 0 0
Olomouc
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Czechia
State/province [55] 0 0
Praha 2
Country [56] 0 0
Czechia
State/province [56] 0 0
Praha
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Denmark
State/province [57] 0 0
Vejle
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France
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Besancon
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France
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Clermont Ferrand
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France
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Lille
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France
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Marseille
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France
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Montpellier
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France
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Nancy
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France
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Paris
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France
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Poitiers
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France
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Saint Cloud
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France
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St Priest En Jarez
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Germany
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Essen
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
State/province [75] 0 0
Minden
Country [76] 0 0
Germany
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Muenchen
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Germany
State/province [77] 0 0
Trier
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Larissa
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Guatemala
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Guatemala City
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Guatemala
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Guatemala
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Hungary
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Budapest
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Hungary
State/province [84] 0 0
Pécs
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Italy
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Calabria
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lombardia
Country [89] 0 0
Italy
State/province [89] 0 0
Sicilia
Country [90] 0 0
Italy
State/province [90] 0 0
Toscana
Country [91] 0 0
Italy
State/province [91] 0 0
Umbria
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Japan
State/province [92] 0 0
Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Iwate
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Okayama
Country [108] 0 0
Japan
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Osaka
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Japan
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Saitama
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Japan
State/province [110] 0 0
Shizuoka
Country [111] 0 0
Japan
State/province [111] 0 0
Tokyo
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
State/province [113] 0 0
Seoul
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Malaysia
State/province [114] 0 0
FED. Territory OF Kuala Lumpur
Country [115] 0 0
Malaysia
State/province [115] 0 0
Selangor
Country [116] 0 0
Mexico
State/province [116] 0 0
Guerrero
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Mexico
State/province [117] 0 0
Nuevo LEON
Country [118] 0 0
Mexico
State/province [118] 0 0
Oaxaca
Country [119] 0 0
Mexico
State/province [119] 0 0
Sonora
Country [120] 0 0
Mexico
State/province [120] 0 0
Aguascalientes
Country [121] 0 0
Mexico
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Toluca
Country [122] 0 0
New Zealand
State/province [122] 0 0
Auckland
Country [123] 0 0
New Zealand
State/province [123] 0 0
Hamilton
Country [124] 0 0
North Macedonia
State/province [124] 0 0
Skopje
Country [125] 0 0
Panama
State/province [125] 0 0
Panama
Country [126] 0 0
Peru
State/province [126] 0 0
Arequipa
Country [127] 0 0
Peru
State/province [127] 0 0
Lima
Country [128] 0 0
Peru
State/province [128] 0 0
Piura
Country [129] 0 0
Philippines
State/province [129] 0 0
Cebu City
Country [130] 0 0
Philippines
State/province [130] 0 0
San Juan
Country [131] 0 0
Poland
State/province [131] 0 0
Bydgoszcz
Country [132] 0 0
Poland
State/province [132] 0 0
Gdansk
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Poland
State/province [133] 0 0
Krakow
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Poland
State/province [134] 0 0
Lublin
Country [135] 0 0
Poland
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Warszawa
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Portugal
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Porto
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Romania
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Bucharest
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Romania
State/province [138] 0 0
Cluj Napoca
Country [139] 0 0
Romania
State/province [139] 0 0
Cluj-Napoca
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Russian Federation
State/province [140] 0 0
Moskovskaja Oblast
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Russian Federation
State/province [141] 0 0
Rjazan
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Russian Federation
State/province [142] 0 0
Stavropol
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Russian Federation
State/province [143] 0 0
Tatarstan
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Russian Federation
State/province [144] 0 0
Ivanovo
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Russian Federation
State/province [145] 0 0
Samara
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Tula
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Vladimir
Country [148] 0 0
Spain
State/province [148] 0 0
Alicante
Country [149] 0 0
Spain
State/province [149] 0 0
Barcelona
Country [150] 0 0
Spain
State/province [150] 0 0
LA Coruña
Country [151] 0 0
Spain
State/province [151] 0 0
Jaen
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Spain
State/province [152] 0 0
La Coruña
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Spain
State/province [153] 0 0
Madrid
Country [154] 0 0
Spain
State/province [154] 0 0
Malaga
Country [155] 0 0
Spain
State/province [155] 0 0
Valencia
Country [156] 0 0
Sweden
State/province [156] 0 0
Malmö
Country [157] 0 0
Switzerland
State/province [157] 0 0
Baden
Country [158] 0 0
Switzerland
State/province [158] 0 0
Basel
Country [159] 0 0
Switzerland
State/province [159] 0 0
Chur
Country [160] 0 0
Taiwan
State/province [160] 0 0
Changhua
Country [161] 0 0
Taiwan
State/province [161] 0 0
Kaohsiung
Country [162] 0 0
Taiwan
State/province [162] 0 0
Taipei
Country [163] 0 0
Thailand
State/province [163] 0 0
Bangkok
Country [164] 0 0
Thailand
State/province [164] 0 0
Chiang Mai
Country [165] 0 0
Thailand
State/province [165] 0 0
Songkhla
Country [166] 0 0
Turkey
State/province [166] 0 0
Adana
Country [167] 0 0
Turkey
State/province [167] 0 0
Ankara
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Turkey
State/province [168] 0 0
Izmir
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Bristol
Country [170] 0 0
United Kingdom
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Cambridge
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United Kingdom
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Cornwall
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Glasgow
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United Kingdom
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Leicester
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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United Kingdom
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Peterborough
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United Kingdom
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Portsmouth
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United Kingdom
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Sheffield
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Southampton
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Stoke-on-Trent
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United Kingdom
State/province [182] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01120184