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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00528567




Registration number
NCT00528567
Ethics application status
Date submitted
11/09/2007
Date registered
12/09/2007
Date last updated
4/09/2015

Titles & IDs
Public title
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
Scientific title
An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.
Secondary ID [1] 0 0
2007-001128-11
Secondary ID [2] 0 0
BO20289
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 - Bevacizumab
Treatment: Drugs - Standard adjuvant chemotherapy

Experimental: Bevacizumab and Chemotherapy - Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.

Active comparator: Chemotherapy - Participants randomized to receive standard adjuvant chemotherapy as prescribed.


Treatment: Drugs: Bevacizumab
Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.

Treatment: Drugs: Standard adjuvant chemotherapy
All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Invasive Disease-free Survival (IDFS) Event
Timepoint [1] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Primary outcome [2] 0 0
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
Timepoint [2] 0 0
Event driven (until data cutoff: 29 February 2012 up to 49 months)
Primary outcome [3] 0 0
Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
Timepoint [3] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Primary outcome [4] 0 0
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
Timepoint [4] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [1] 0 0
Time to Overall Survival (OS) Event
Timepoint [1] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [2] 0 0
Time to Overall Survival (OS) Event
Timepoint [2] 0 0
Event driven (until data cutoff: 30 June 2014: up to 77 months)
Secondary outcome [3] 0 0
Percentage of Participants With Overall Survival (OS) Event
Timepoint [3] 0 0
Event driven (until data cut off: 29 February 2012: up to 49 months)
Secondary outcome [4] 0 0
Percentage of Participants With Overall Survival (OS) Event
Timepoint [4] 0 0
Event driven (until data cut off: 30 June 2014: up to 77 months)
Secondary outcome [5] 0 0
Time to Breast Cancer-Free Interval (BCFI) Event
Timepoint [5] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [6] 0 0
Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events
Timepoint [6] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [7] 0 0
Time to Disease-Free Survival (DFS) Event
Timepoint [7] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [8] 0 0
Percentage of Participants With Disease-Free Survival (DFS) Events
Timepoint [8] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [9] 0 0
Time to Distant Disease-Free Survival (DDFS) Event
Timepoint [9] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [10] 0 0
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events
Timepoint [10] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [11] 0 0
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths
Timepoint [11] 0 0
Through end of study: 30 June 2014: up to 77 months

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* operable primary invasive breast cancer;
* completed definitive loco-regional surgery;
* primary tumor centrally confirmed as triple negative.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* locally advanced breast cancers;
* previous breast cancer history;
* clinically significant cardiovascular disease.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
2591
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- East Bentleigh
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Heidelberg
Recruitment hospital [7] 0 0
- Kurralta Park
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Nambour
Recruitment hospital [10] 0 0
- Parkville
Recruitment hospital [11] 0 0
- Perth
Recruitment hospital [12] 0 0
- Port Macquarie
Recruitment hospital [13] 0 0
- St. Leonards
Recruitment hospital [14] 0 0
- Sydney
Recruitment hospital [15] 0 0
- Wahroonga
Recruitment hospital [16] 0 0
- Waratah
Recruitment hospital [17] 0 0
- Wodonga
Recruitment hospital [18] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
4104 - Brisbane
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
5035 - Kurralta Park
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
4560 - Nambour
Recruitment postcode(s) [11] 0 0
3052 - Parkville
Recruitment postcode(s) [12] 0 0
6000 - Perth
Recruitment postcode(s) [13] 0 0
6008 - Perth
Recruitment postcode(s) [14] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [15] 0 0
2065 - St. Leonards
Recruitment postcode(s) [16] 0 0
2031 - Sydney
Recruitment postcode(s) [17] 0 0
2060 - Sydney
Recruitment postcode(s) [18] 0 0
2065 - Sydney
Recruitment postcode(s) [19] 0 0
2139 - Sydney
Recruitment postcode(s) [20] 0 0
2076 - Wahroonga
Recruitment postcode(s) [21] 0 0
2298 - Waratah
Recruitment postcode(s) [22] 0 0
3690 - Wodonga
Recruitment postcode(s) [23] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
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Florida
Country [7] 0 0
United States of America
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Georgia
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Illinois
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United States of America
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Iowa
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
State/province [15] 0 0
North Carolina
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United States of America
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Ohio
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South Carolina
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Tennessee
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Texas
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United States of America
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Vermont
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
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Rosario
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Austria
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Bludesch
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Graz
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Innsbruck
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Krems
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Austria
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Leoben
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Linz
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Austria
State/province [30] 0 0
Salzburg
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Austria
State/province [31] 0 0
Wels
Country [32] 0 0
Austria
State/province [32] 0 0
Wiener Neustadt
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Austria
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Wien
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Wolfsberg
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Baudour
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Bruxelles
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Belgium
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Hasselt
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Belgium
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Namur
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Belgium
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Sint-niklaas
Country [40] 0 0
Belgium
State/province [40] 0 0
Tournai
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Belgium
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Wilrijk
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Bosnia and Herzegovina
State/province [42] 0 0
Sarajevo
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Goiania
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Ijui
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JAU
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Hang Zhou
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Le Mans
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Lille
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France
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Nancy
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Neuilly Sur Seine
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France
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France
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Rouen
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France
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Saint-cloud
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Senlis
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Strasbourg
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France
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France
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Tours
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Germany
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Germany
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Bielefeld
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Germany
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Germany
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Chemnitz
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Germany
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Coburg
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Germany
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Dortmund
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Germany
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Dresden
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Germany
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Germany
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Freiburg
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Germany
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Germany
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Greifswald
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Kassel
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Germany
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Kiel
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Germany
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Koeln
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Germany
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Krefeld
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Germany
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Leipzig
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Lüneburg
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Germany
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Magdeburg
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Germany
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Marburg
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Germany
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München
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Germany
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Münster
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Germany
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Offenbach
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Germany
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Offenburg
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Germany
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Recklinghausen
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Germany
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Rosenheim
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Germany
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Stade
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Germany
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Trier
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Germany
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Tübingen
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Germany
State/province [138] 0 0
ULM
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Germany
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Germany
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Germany
State/province [141] 0 0
Witten
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Greece
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Heraklion
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Greece
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Patras
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Ramat-gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Aviano
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Bari
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Brindisi
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Italy
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Candiolo
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Italy
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Cattolica
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Italy
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Cesena
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Italy
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Fano
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Lecce
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Lido Di Camaiore
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Italy
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Livorno
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Lugo
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Mantova
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Italy
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Noale
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Padova
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Palermo
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San Giovanni Rotondo
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Sassari
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Taormina
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Treviglio
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Italy
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Japan
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Aichi
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Japan
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Ehime
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Fukuoka
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Korea, Republic of
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Kyunggi-do
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Korea, Republic of
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Seoul
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Macedonia, The Former Yugoslav Republic of
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Skopje
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Malaysia
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Kelantan
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Malaysia
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Penang
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Malaysia
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Petaling Jaya, Selangor
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Malaysia
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Selangor
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Mexico
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Leon
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Mexico
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Delftzijl
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Den Helder
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Netherlands
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Groningen
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Netherlands
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Tilburg
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New Zealand
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Auckland
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New Zealand
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Wellington
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Peru
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Philippines
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Lublin
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Poznan
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Poland
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Portugal
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Coimbra
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Lisboa
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Ekaterinburg
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Ryazan
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

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/NCT00528567