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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00490139




Registration number
NCT00490139
Ethics application status
Date submitted
20/06/2007
Date registered
22/06/2007

Titles & IDs
Public title
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scientific title
A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer
Secondary ID [1] 0 0
CLAP016B2301
Secondary ID [2] 0 0
EGF106708
Universal Trial Number (UTN)
Trial acronym
ALTTO
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lapatinib
Treatment: Other - Trastuzumab

Experimental: Lapatinib plus Trastuzumab - Design 1: Oral lapatinib 1000 mg daily concurrent with trastuzumab 8 mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks (52 weeks total).

Design 2: Trastuzumab (4mg/kg loading dose followed by 2mg/kg IV weekly) concurrent with oral lapatinib 750 mg daily and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles (12 weeks). After completion of chemotherapy, the dose of lapatinib will be increased to 1000mg daily concurrently with trastuzumab every 3 weeks (6mg/kg without loading dose) for an additional 40 weeks (52 weeks total).

Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concurrently with oral lapatinib 750mg plus weekly trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV. After the completion of chemotherapy, trastuzumab will be administered every 3 weeks (6mg/kg without loading dose) concurrent with lapatinib 1000mg daily for an additional 40 weeks (52 weeks total).

Experimental: Trastuzumab followed by Lapatinib - Design 1: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total).

Design 2: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks administered concomitantly and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles; followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total).

Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) followed by a 6 week treatment-free interval followed by oral lapatinib 1500 mg daily for 28 weeks (52 weeks total).

Experimental: Lapatinib - Design 1: Lapatinib 1500mg oral daily for a total of 52 weeks.

Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, oral lapatinib administered at 1500mg daily for an additional 40 weeks (52 weeks total).

Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, the dose of lapatinib will be increased to 1500mg oral daily for an additional 40 weeks (52 weeks total).

Active comparator: Trastuzumab - Design 1: Trastuzumab 8mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks for a total of 52 weeks.

Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab administered every 3 weeks (6mg/kg IV without loading dose) for an additional 40 weeks (52 weeks total).

Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab (6mg/kg without loading dose) every 3 weeks for an additional 40 weeks (52 weeks total).


Treatment: Drugs: Lapatinib
Small molecule inhibitor

Treatment: Other: Trastuzumab
Antibody
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival (DFS) at the Primary Analysis
Timepoint [1] 0 0
From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
Secondary outcome [1] 0 0
Disease-Free Survival (DFS) at the 10-Year Follow-Up
Timepoint [1] 0 0
From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years
Secondary outcome [2] 0 0
Overall Survival (OS) at the Primary Analysis
Timepoint [2] 0 0
From randomization until death due to any cause (median follow-up of 4.5 years)
Secondary outcome [3] 0 0
Overall Survival (OS) at the 10-Year Follow-Up
Timepoint [3] 0 0
From randomization until death due to any cause, assessed up to approximately 10 years
Secondary outcome [4] 0 0
Analysis of Time to Recurrence (TTR)
Timepoint [4] 0 0
From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
Secondary outcome [5] 0 0
Analysis of Time to Distant Recurrence (TTDR)
Timepoint [5] 0 0
From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years
Secondary outcome [6] 0 0
Analysis of Time to Central Nervous System (CNS) Recurrence
Timepoint [6] 0 0
From randomization until the first central nervous system recurrence, assessed up to approximately 10 years
Secondary outcome [7] 0 0
Cumulative Incidence of Brain Metastases
Timepoint [7] 0 0
From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years

Eligibility
Key inclusion criteria
Key

* Patients >= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF >= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status =< 1, were included.
* For Designs 1 and 2: Patients must have had received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or a protocol specified exception.
* Approved, signed written informed consent obtained prior to any study specific screening procedures.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of any prior (ipsi- and/or contralateral) invasive breast carcinoma, past (less than 10 years) or current history of malignant neoplasms, any clinically staged T4 tumor, or bilateral tumors.
* Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer;
* Patients with positive or suspicious internal mammary nodes identified by sentinel node technique, which had not been irradiated or would not be irradiated, or patients with supraclavicular lymph node involvement.
* Any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa)
* (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;
* Serious cardiac illness or medical conditions.
* Any of the following abnormal laboratory tests immediately prior to randomization:

1. Serum total bilirubin >1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 x ULN) was allowed;
2. Alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 x ULN;
3. Alkaline phosphatase (ALP) >2.5 x ULN;
4. Serum creatinine >2.0 x ULN;
5. Total white blood cell count (WBC) <2.5 x 10^9/L;
6. Absolute neutrophil count <1.5 x 10^9/L;
7. Platelets <100 x 10^9/L.
* Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women.
* Concomitant use of CYP3A4 inhibitors or inducers.

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
16/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2021
Sample size
Target
Accrual to date
Final
8381
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [2] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [4] 0 0
Novartis Investigative Site - Bunbury
Recruitment hospital [5] 0 0
Novartis Investigative Site - Campbelltown
Recruitment hospital [6] 0 0
Novartis Investigative Site - Camperdown
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Novartis Investigative Site - Coffs Harbour
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Novartis Investigative Site - Concord
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Novartis Investigative Site - East Bentleigh
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Novartis Investigative Site - East Melbourne
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Novartis Investigative Site - Heidelberg
Recruitment hospital [12] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [13] 0 0
Novartis Investigative Site - Lismore
Recruitment hospital [14] 0 0
Novartis Investigative Site - Liverpool
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Novartis Investigative Site - Melbourne
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Novartis Investigative Site - Murdoch
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Novartis Investigative Site - Nambour
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Novartis Investigative Site - Nedlands
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Novartis Investigative Site - North Sydney
Recruitment hospital [20] 0 0
Novartis Investigative Site - Parkville
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Novartis Investigative Site - Port Macquarie
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Novartis Investigative Site - South Brisbane
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Novartis Investigative Site - Wagga Wagga
Recruitment hospital [28] 0 0
Novartis Investigative Site - Waratah
Recruitment hospital [29] 0 0
Novartis Investigative Site - Wendouree
Recruitment hospital [30] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [31] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [32] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
6230 - Bunbury
Recruitment postcode(s) [5] 0 0
2560 - Campbelltown
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2050 - Camperdown
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2450 - Coffs Harbour
Recruitment postcode(s) [8] 0 0
2139 - Concord
Recruitment postcode(s) [9] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [10] 0 0
3002 - East Melbourne
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
2480 - Lismore
Recruitment postcode(s) [14] 0 0
2170 - Liverpool
Recruitment postcode(s) [15] 0 0
3002 - Melbourne
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment postcode(s) [17] 0 0
4560 - Nambour
Recruitment postcode(s) [18] 0 0
6009 - Nedlands
Recruitment postcode(s) [19] 0 0
2060 - North Sydney
Recruitment postcode(s) [20] 0 0
3050 - Parkville
Recruitment postcode(s) [21] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [22] 0 0
2031 - Randwick
Recruitment postcode(s) [23] 0 0
4101 - South Brisbane
Recruitment postcode(s) [24] 0 0
6008 - Subiaco
Recruitment postcode(s) [25] 0 0
2430 - Taree
Recruitment postcode(s) [26] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [27] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [28] 0 0
2298 - Waratah
Recruitment postcode(s) [29] 0 0
3355 - Wendouree
Recruitment postcode(s) [30] 0 0
2145 - Westmead
Recruitment postcode(s) [31] 0 0
5011 - Woodville
Recruitment postcode(s) [32] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Georgia
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Aalborg
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Vejle
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France
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France
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France
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France
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France
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France
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France
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Bron
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France
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France
State/province [149] 0 0
Clermont Ferrand
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France
State/province [150] 0 0
Coudekerque Branche
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France
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Dijon
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France
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France
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Grenoble
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France
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Hyeres
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France
State/province [155] 0 0
La Seyne Sur Mer
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France
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Le Mans
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Metz
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France
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Mont de Marsan
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France
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Montbeliard
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France
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Nancy
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France
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Nice
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France
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Nimes
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France
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Paris
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France
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Perigueux
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France
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Perin Sur Mer
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France
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Perpignan
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France
State/province [170] 0 0
Reims
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France
State/province [171] 0 0
Rouen
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France
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Saint Gregoire
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France
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Saint Jean
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France
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Saint-Cloud
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France
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Saint-Herblain
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France
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Saint-Priest en Jarez
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France
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Strasbourg
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France
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France
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Tours
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France
State/province [180] 0 0
Valenciennes
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France
State/province [181] 0 0
Vandoeuvre-Les-Nancy
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France
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Villejuif
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Germany
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Ansbach
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Germany
State/province [184] 0 0
Aschaffenburg
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Germany
State/province [185] 0 0
Aschersleben
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Germany
State/province [186] 0 0
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Germany
State/province [187] 0 0
Bad Oldesloe
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Germany
State/province [188] 0 0
Bad Reichenhall
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Germany
State/province [189] 0 0
Baden-Baden
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Germany
State/province [190] 0 0
Bayreuth
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Germany
State/province [191] 0 0
Bergisch Gladbach
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Germany
State/province [192] 0 0
Berlin
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Germany
State/province [193] 0 0
Bielefeld
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Germany
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Boeblingen
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Germany
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Bonn
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Germany
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Brandenburg
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Germany
State/province [197] 0 0
Braunschweig
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Germany
State/province [198] 0 0
Bremen
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Germany
State/province [199] 0 0
Bremerhaven
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Germany
State/province [200] 0 0
Chemnitz
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Germany
State/province [201] 0 0
Coburg
Country [202] 0 0
Germany
State/province [202] 0 0
Cuxhaven
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Germany
State/province [203] 0 0
Dachau
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Germany
State/province [204] 0 0
Deggendorf
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Germany
State/province [205] 0 0
Donauwoerth
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Germany
State/province [206] 0 0
Dresden
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Germany
State/province [207] 0 0
Duesseldorf
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Germany
State/province [208] 0 0
Duisburg
Country [209] 0 0
Germany
State/province [209] 0 0
Eggenfelden
Country [210] 0 0
Germany
State/province [210] 0 0
Erfurt
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Germany
State/province [211] 0 0
Erlangen
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Germany
State/province [212] 0 0
Eschweiler
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Germany
State/province [213] 0 0
Essen
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Germany
State/province [214] 0 0
Esslingen
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Germany
State/province [215] 0 0
Flensburg
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Germany
State/province [216] 0 0
Frankfurt am Main
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Germany
State/province [217] 0 0
Frankfurt
Country [218] 0 0
Germany
State/province [218] 0 0
Freiburg
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Germany
State/province [219] 0 0
Friedrichshafen
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Germany
State/province [220] 0 0
Fuerstenwalde
Country [221] 0 0
Germany
State/province [221] 0 0
Fuerth
Country [222] 0 0
Germany
State/province [222] 0 0
Garmisch-Partenkirchen
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Germany
State/province [223] 0 0
Georgsmarienhuette
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Germany
State/province [224] 0 0
Gera
Country [225] 0 0
Germany
State/province [225] 0 0
Goeppingen
Country [226] 0 0
Germany
State/province [226] 0 0
Goettingen
Country [227] 0 0
Germany
State/province [227] 0 0
Goslar
Country [228] 0 0
Germany
State/province [228] 0 0
Greifswald
Country [229] 0 0
Germany
State/province [229] 0 0
Guestrow
Country [230] 0 0
Germany
State/province [230] 0 0
Gummersbach
Country [231] 0 0
Germany
State/province [231] 0 0
Halle
Country [232] 0 0
Germany
State/province [232] 0 0
Hamburg
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Germany
State/province [233] 0 0
Hameln
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Germany
State/province [234] 0 0
Hamm-Heessen
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Germany
State/province [235] 0 0
Hannover
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Germany
State/province [236] 0 0
Heidelberg
Country [237] 0 0
Germany
State/province [237] 0 0
Heide
Country [238] 0 0
Germany
State/province [238] 0 0
Herne
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Germany
State/province [239] 0 0
Homburg
Country [240] 0 0
Germany
State/province [240] 0 0
Hoyerswerda
Country [241] 0 0
Germany
State/province [241] 0 0
Itzehoe
Country [242] 0 0
Germany
State/province [242] 0 0
Jena
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Germany
State/province [243] 0 0
Karlsruhe
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Germany
State/province [244] 0 0
Kassel
Country [245] 0 0
Germany
State/province [245] 0 0
Kempten
Country [246] 0 0
Germany
State/province [246] 0 0
Kiel
Country [247] 0 0
Germany
State/province [247] 0 0
Koeln
Country [248] 0 0
Germany
State/province [248] 0 0
Konstanz
Country [249] 0 0
Germany
State/province [249] 0 0
Landshut
Country [250] 0 0
Germany
State/province [250] 0 0
Landstuhl
Country [251] 0 0
Germany
State/province [251] 0 0
Leer
Country [252] 0 0
Germany
State/province [252] 0 0
Leipzig
Country [253] 0 0
Germany
State/province [253] 0 0
Leverkusen
Country [254] 0 0
Germany
State/province [254] 0 0
Limburg
Country [255] 0 0
Germany
State/province [255] 0 0
Loerrach
Country [256] 0 0
Germany
State/province [256] 0 0
Luckenwalde
Country [257] 0 0
Germany
State/province [257] 0 0
Ludwigsburg
Country [258] 0 0
Germany
State/province [258] 0 0
Ludwigsfelde
Country [259] 0 0
Germany
State/province [259] 0 0
Ludwigshafen
Country [260] 0 0
Germany
State/province [260] 0 0
Luebeck
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Germany
State/province [261] 0 0
Magdeburg
Country [262] 0 0
Germany
State/province [262] 0 0
Mainz
Country [263] 0 0
Germany
State/province [263] 0 0
Mannheim
Country [264] 0 0
Germany
State/province [264] 0 0
Marktredwitz
Country [265] 0 0
Germany
State/province [265] 0 0
Meiningen
Country [266] 0 0
Germany
State/province [266] 0 0
Memmingen
Country [267] 0 0
Germany
State/province [267] 0 0
Minden
Country [268] 0 0
Germany
State/province [268] 0 0
Moenchengladbach
Country [269] 0 0
Germany
State/province [269] 0 0
Muehlhausen
Country [270] 0 0
Germany
State/province [270] 0 0
Muenchen
Country [271] 0 0
Germany
State/province [271] 0 0
Muenster
Country [272] 0 0
Germany
State/province [272] 0 0
Munchen
Country [273] 0 0
Germany
State/province [273] 0 0
Mutlangen
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Germany
State/province [274] 0 0
Neumuenster
Country [275] 0 0
Germany
State/province [275] 0 0
Neunkirchen
Country [276] 0 0
Germany
State/province [276] 0 0
Nuernberg
Country [277] 0 0
Germany
State/province [277] 0 0
Offenbach
Country [278] 0 0
Germany
State/province [278] 0 0
Oldenburg
Country [279] 0 0
Germany
State/province [279] 0 0
Olpe
Country [280] 0 0
Germany
State/province [280] 0 0
Osnabrueck
Country [281] 0 0
Germany
State/province [281] 0 0
Ostfildern
Country [282] 0 0
Germany
State/province [282] 0 0
Porta Westfalica
Country [283] 0 0
Germany
State/province [283] 0 0
Radebeul
Country [284] 0 0
Germany
State/province [284] 0 0
Ravensburg
Country [285] 0 0
Germany
State/province [285] 0 0
Rendsburg
Country [286] 0 0
Germany
State/province [286] 0 0
Reutlingen
Country [287] 0 0
Germany
State/province [287] 0 0
Rheinfelden
Country [288] 0 0
Germany
State/province [288] 0 0
Rodewisch
Country [289] 0 0
Germany
State/province [289] 0 0
Rosenheim
Country [290] 0 0
Germany
State/province [290] 0 0
Rostock
Country [291] 0 0
Germany
State/province [291] 0 0
Rotenburg
Country [292] 0 0
Germany
State/province [292] 0 0
Saarbruecken
Country [293] 0 0
Germany
State/province [293] 0 0
Schkeuditz
Country [294] 0 0
Germany
State/province [294] 0 0
Schwaebisch Hall
Country [295] 0 0
Germany
State/province [295] 0 0
Sigmaringen
Country [296] 0 0
Germany
State/province [296] 0 0
Stade
Country [297] 0 0
Germany
State/province [297] 0 0
Stadthagen
Country [298] 0 0
Germany
State/province [298] 0 0
Stendal
Country [299] 0 0
Germany
State/province [299] 0 0
Stralsund
Country [300] 0 0
Germany
State/province [300] 0 0
Stuttgart
Country [301] 0 0
Germany
State/province [301] 0 0
Torgau
Country [302] 0 0
Germany
State/province [302] 0 0
Trier
Country [303] 0 0
Germany
State/province [303] 0 0
Troisdorf
Country [304] 0 0
Germany
State/province [304] 0 0
Tuebingen
Country [305] 0 0
Germany
State/province [305] 0 0
Ulm
Country [306] 0 0
Germany
State/province [306] 0 0
Vechta
Country [307] 0 0
Germany
State/province [307] 0 0
Velbert
Country [308] 0 0
Germany
State/province [308] 0 0
Villingen-Schwenningen
Country [309] 0 0
Germany
State/province [309] 0 0
Weissenfels
Country [310] 0 0
Germany
State/province [310] 0 0
Wesel
Country [311] 0 0
Germany
State/province [311] 0 0
Westerstede
Country [312] 0 0
Germany
State/province [312] 0 0
Wiesbaden
Country [313] 0 0
Germany
State/province [313] 0 0
Witten
Country [314] 0 0
Germany
State/province [314] 0 0
Wuerselen
Country [315] 0 0
Germany
State/province [315] 0 0
Wuerzburg
Country [316] 0 0
Germany
State/province [316] 0 0
Wuppertal
Country [317] 0 0
Germany
State/province [317] 0 0
Zittau
Country [318] 0 0
Germany
State/province [318] 0 0
Zwickau
Country [319] 0 0
Greece
State/province [319] 0 0
Athens
Country [320] 0 0
Greece
State/province [320] 0 0
Heraklion
Country [321] 0 0
Greece
State/province [321] 0 0
Patra
Country [322] 0 0
Greece
State/province [322] 0 0
Thessaloniki
Country [323] 0 0
Hong Kong
State/province [323] 0 0
Kowloon
Country [324] 0 0
Hong Kong
State/province [324] 0 0
Tuen Mun
Country [325] 0 0
Hungary
State/province [325] 0 0
Budapest
Country [326] 0 0
Hungary
State/province [326] 0 0
Gyor
Country [327] 0 0
Hungary
State/province [327] 0 0
Szeged
Country [328] 0 0
India
State/province [328] 0 0
Gurgaon
Country [329] 0 0
India
State/province [329] 0 0
Hyderabad
Country [330] 0 0
India
State/province [330] 0 0
Kolkatta
Country [331] 0 0
India
State/province [331] 0 0
Mumbai
Country [332] 0 0
India
State/province [332] 0 0
Nagpur
Country [333] 0 0
India
State/province [333] 0 0
New Delhi
Country [334] 0 0
India
State/province [334] 0 0
Trivandrum
Country [335] 0 0
Ireland
State/province [335] 0 0
Cork
Country [336] 0 0
Ireland
State/province [336] 0 0
Dublin
Country [337] 0 0
Ireland
State/province [337] 0 0
Galway
Country [338] 0 0
Israel
State/province [338] 0 0
Beer-Sheva
Country [339] 0 0
Israel
State/province [339] 0 0
Haifa
Country [340] 0 0
Israel
State/province [340] 0 0
Holon
Country [341] 0 0
Israel
State/province [341] 0 0
Jerusalem
Country [342] 0 0
Israel
State/province [342] 0 0
Netanya
Country [343] 0 0
Israel
State/province [343] 0 0
Ramat Gan
Country [344] 0 0
Israel
State/province [344] 0 0
Tel Aviv
Country [345] 0 0
Israel
State/province [345] 0 0
Zrifin
Country [346] 0 0
Italy
State/province [346] 0 0
Asti
Country [347] 0 0
Italy
State/province [347] 0 0
Avellino
Country [348] 0 0
Italy
State/province [348] 0 0
Aviano
Country [349] 0 0
Italy
State/province [349] 0 0
Bergamo
Country [350] 0 0
Italy
State/province [350] 0 0
Biella
Country [351] 0 0
Italy
State/province [351] 0 0
Brescia
Country [352] 0 0
Italy
State/province [352] 0 0
Brindisi
Country [353] 0 0
Italy
State/province [353] 0 0
Candiolo
Country [354] 0 0
Italy
State/province [354] 0 0
Carpi
Country [355] 0 0
Italy
State/province [355] 0 0
Cosenza
Country [356] 0 0
Italy
State/province [356] 0 0
Cremona
Country [357] 0 0
Italy
State/province [357] 0 0
Fano
Country [358] 0 0
Italy
State/province [358] 0 0
Fermo
Country [359] 0 0
Italy
State/province [359] 0 0
Firenze
Country [360] 0 0
Italy
State/province [360] 0 0
Genova
Country [361] 0 0
Italy
State/province [361] 0 0
Lecce
Country [362] 0 0
Italy
State/province [362] 0 0
Lecco
Country [363] 0 0
Italy
State/province [363] 0 0
Lido di Camaiore
Country [364] 0 0
Italy
State/province [364] 0 0
Livorno
Country [365] 0 0
Italy
State/province [365] 0 0
Mantova
Country [366] 0 0
Italy
State/province [366] 0 0
Meldola
Country [367] 0 0
Italy
State/province [367] 0 0
Milano
Country [368] 0 0
Italy
State/province [368] 0 0
Monserrato
Country [369] 0 0
Italy
State/province [369] 0 0
Monza
Country [370] 0 0
Italy
State/province [370] 0 0
Pavia
Country [371] 0 0
Italy
State/province [371] 0 0
Poggibonsi
Country [372] 0 0
Italy
State/province [372] 0 0
Potenza
Country [373] 0 0
Italy
State/province [373] 0 0
Prato
Country [374] 0 0
Italy
State/province [374] 0 0
Ragusa
Country [375] 0 0
Italy
State/province [375] 0 0
Ravenna
Country [376] 0 0
Italy
State/province [376] 0 0
Rimini
Country [377] 0 0
Italy
State/province [377] 0 0
Rozzano
Country [378] 0 0
Italy
State/province [378] 0 0
San Fermo della Battaglia
Country [379] 0 0
Italy
State/province [379] 0 0
Saronno
Country [380] 0 0
Italy
State/province [380] 0 0
Sassari
Country [381] 0 0
Italy
State/province [381] 0 0
Trento
Country [382] 0 0
Italy
State/province [382] 0 0
Treviglio
Country [383] 0 0
Italy
State/province [383] 0 0
Udine
Country [384] 0 0
Italy
State/province [384] 0 0
Varese
Country [385] 0 0
Italy
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Viterbo
Country [386] 0 0
Japan
State/province [386] 0 0
Aichi
Country [387] 0 0
Japan
State/province [387] 0 0
Chiba
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Japan
State/province [388] 0 0
Ehime
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Japan
State/province [389] 0 0
Fukuoka
Country [390] 0 0
Japan
State/province [390] 0 0
Ibaraki
Country [391] 0 0
Japan
State/province [391] 0 0
Kanagawa
Country [392] 0 0
Japan
State/province [392] 0 0
Kyoto
Country [393] 0 0
Japan
State/province [393] 0 0
Osaka
Country [394] 0 0
Japan
State/province [394] 0 0
Saitama
Country [395] 0 0
Japan
State/province [395] 0 0
Tokyo
Country [396] 0 0
Korea, Republic of
State/province [396] 0 0
Gyeonggi-do
Country [397] 0 0
Korea, Republic of
State/province [397] 0 0
Incheon
Country [398] 0 0
Korea, Republic of
State/province [398] 0 0
Seoul
Country [399] 0 0
Mexico
State/province [399] 0 0
Chihuahua
Country [400] 0 0
Mexico
State/province [400] 0 0
Mexico City
Country [401] 0 0
Mexico
State/province [401] 0 0
Mexico
Country [402] 0 0
Mexico
State/province [402] 0 0
Toluca
Country [403] 0 0
Netherlands
State/province [403] 0 0
Amsterdam
Country [404] 0 0
Netherlands
State/province [404] 0 0
Arnhem
Country [405] 0 0
Netherlands
State/province [405] 0 0
Delft
Country [406] 0 0
Netherlands
State/province [406] 0 0
Den Haag
Country [407] 0 0
Netherlands
State/province [407] 0 0
Eindhoven
Country [408] 0 0
Netherlands
State/province [408] 0 0
Gouda
Country [409] 0 0
Netherlands
State/province [409] 0 0
Hilversum
Country [410] 0 0
Netherlands
State/province [410] 0 0
Hoogeveen
Country [411] 0 0
Netherlands
State/province [411] 0 0
Leeuwarden
Country [412] 0 0
Netherlands
State/province [412] 0 0
Leiden
Country [413] 0 0
Netherlands
State/province [413] 0 0
Leidschendam
Country [414] 0 0
Netherlands
State/province [414] 0 0
Purmerend
Country [415] 0 0
Netherlands
State/province [415] 0 0
Rotterdam
Country [416] 0 0
Netherlands
State/province [416] 0 0
Sittard-Geleen
Country [417] 0 0
Netherlands
State/province [417] 0 0
Tilburg
Country [418] 0 0
Netherlands
State/province [418] 0 0
Utrecht
Country [419] 0 0
New Zealand
State/province [419] 0 0
Hamilton
Country [420] 0 0
New Zealand
State/province [420] 0 0
Palmerston North
Country [421] 0 0
New Zealand
State/province [421] 0 0
Wellington
Country [422] 0 0
Norway
State/province [422] 0 0
Oslo
Country [423] 0 0
Norway
State/province [423] 0 0
Tromso
Country [424] 0 0
Pakistan
State/province [424] 0 0
Karachi
Country [425] 0 0
Pakistan
State/province [425] 0 0
Lahore
Country [426] 0 0
Pakistan
State/province [426] 0 0
Rawalpindi
Country [427] 0 0
Peru
State/province [427] 0 0
Callao
Country [428] 0 0
Peru
State/province [428] 0 0
Lima
Country [429] 0 0
Philippines
State/province [429] 0 0
Cebu
Country [430] 0 0
Philippines
State/province [430] 0 0
Quezon City
Country [431] 0 0
Philippines
State/province [431] 0 0
Sampaloc
Country [432] 0 0
Philippines
State/province [432] 0 0
San Juan
Country [433] 0 0
Poland
State/province [433] 0 0
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Poland
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Gdansk
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Poland
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Gliwice
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Poland
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Krakow
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Poland
State/province [437] 0 0
Olsztyn
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Poland
State/province [438] 0 0
Opole
Country [439] 0 0
Poland
State/province [439] 0 0
Rzeszow
Country [440] 0 0
Poland
State/province [440] 0 0
Szczecin
Country [441] 0 0
Poland
State/province [441] 0 0
Warszawa
Country [442] 0 0
Poland
State/province [442] 0 0
Wroclaw
Country [443] 0 0
Romania
State/province [443] 0 0
Bucharest
Country [444] 0 0
Romania
State/province [444] 0 0
Bucuresti
Country [445] 0 0
Romania
State/province [445] 0 0
Cluj-Napoca
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Romania
State/province [446] 0 0
Iasi
Country [447] 0 0
Russian Federation
State/province [447] 0 0
Arkhangelsk
Country [448] 0 0
Russian Federation
State/province [448] 0 0
Chelyabinsk
Country [449] 0 0
Russian Federation
State/province [449] 0 0
Irkutsk
Country [450] 0 0
Russian Federation
State/province [450] 0 0
Kazan
Country [451] 0 0
Russian Federation
State/province [451] 0 0
Kirov
Country [452] 0 0
Russian Federation
State/province [452] 0 0
Moscow
Country [453] 0 0
Russian Federation
State/province [453] 0 0
Novosibirsk
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Russian Federation
State/province [454] 0 0
Omsk
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Russian Federation
State/province [455] 0 0
Orenburg
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Russian Federation
State/province [456] 0 0
Ryazan
Country [457] 0 0
Russian Federation
State/province [457] 0 0
Samara
Country [458] 0 0
Russian Federation
State/province [458] 0 0
St. Petersburg
Country [459] 0 0
Russian Federation
State/province [459] 0 0
Voronezh
Country [460] 0 0
Singapore
State/province [460] 0 0
Singapore
Country [461] 0 0
Slovakia
State/province [461] 0 0
Bratislava
Country [462] 0 0
Slovakia
State/province [462] 0 0
Kosice
Country [463] 0 0
Slovakia
State/province [463] 0 0
Poprad
Country [464] 0 0
Slovakia
State/province [464] 0 0
Zilina
Country [465] 0 0
Slovenia
State/province [465] 0 0
Ljubljana
Country [466] 0 0
South Africa
State/province [466] 0 0
Capital Park
Country [467] 0 0
South Africa
State/province [467] 0 0
Groenkloof
Country [468] 0 0
South Africa
State/province [468] 0 0
Johannesburg
Country [469] 0 0
South Africa
State/province [469] 0 0
Observatory
Country [470] 0 0
South Africa
State/province [470] 0 0
Panorama
Country [471] 0 0
South Africa
State/province [471] 0 0
Parktown
Country [472] 0 0
South Africa
State/province [472] 0 0
Pretoria
Country [473] 0 0
Spain
State/province [473] 0 0
Alcoy
Country [474] 0 0
Spain
State/province [474] 0 0
Barcelona
Country [475] 0 0
Spain
State/province [475] 0 0
Burgos
Country [476] 0 0
Spain
State/province [476] 0 0
Cadiz
Country [477] 0 0
Spain
State/province [477] 0 0
Castellon
Country [478] 0 0
Spain
State/province [478] 0 0
Cordoba
Country [479] 0 0
Spain
State/province [479] 0 0
Elda
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Spain
State/province [480] 0 0
Granada
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Spain
State/province [481] 0 0
Lerida
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Spain
State/province [482] 0 0
Lugo
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Spain
State/province [483] 0 0
Madrid
Country [484] 0 0
Spain
State/province [484] 0 0
Malaga
Country [485] 0 0
Spain
State/province [485] 0 0
Mataro
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Spain
State/province [486] 0 0
Mostoles
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Spain
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Murcia
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Spain
State/province [488] 0 0
Palma de Mallorca
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Spain
State/province [489] 0 0
Pamplona
Country [490] 0 0
Spain
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Salamanca
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Spain
State/province [491] 0 0
San Sebastian
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Spain
State/province [492] 0 0
Santa Cruz de Tenerife
Country [493] 0 0
Spain
State/province [493] 0 0
Santander
Country [494] 0 0
Spain
State/province [494] 0 0
Santiago
Country [495] 0 0
Spain
State/province [495] 0 0
Segovia
Country [496] 0 0
Spain
State/province [496] 0 0
Sevilla
Country [497] 0 0
Spain
State/province [497] 0 0
Tarrasa, Barcelona
Country [498] 0 0
Spain
State/province [498] 0 0
Toledo
Country [499] 0 0
Spain
State/province [499] 0 0
Valencia
Country [500] 0 0
Spain
State/province [500] 0 0
Vizcaya
Country [501] 0 0
Spain
State/province [501] 0 0
Zamora
Country [502] 0 0
Switzerland
State/province [502] 0 0
Aarau
Country [503] 0 0
Switzerland
State/province [503] 0 0
Basel
Country [504] 0 0
Switzerland
State/province [504] 0 0
Bellinzona
Country [505] 0 0
Switzerland
State/province [505] 0 0
Chur
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Switzerland
State/province [506] 0 0
Lausanne
Country [507] 0 0
Switzerland
State/province [507] 0 0
Locarno
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Switzerland
State/province [508] 0 0
St Gallen
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Switzerland
State/province [509] 0 0
Thun
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Switzerland
State/province [510] 0 0
Zuerich
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Switzerland
State/province [511] 0 0
Zurich
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Taiwan
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Taichung
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Taiwan
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
State/province [517] 0 0
Chiangmai
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Thailand
State/province [518] 0 0
Khon Kaen
Country [519] 0 0
Thailand
State/province [519] 0 0
Phitsanulok
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Thailand
State/province [520] 0 0
Songkhla
Country [521] 0 0
Ukraine
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Chernivtsi
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Ukraine
State/province [522] 0 0
Donetsk
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Ukraine
State/province [523] 0 0
Kharkiv
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Ukraine
State/province [524] 0 0
Kyiv
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Ukraine
State/province [525] 0 0
Lviv
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Ukraine
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Uzhgorod
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Ukraine
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
State/province [542] 0 0
Gwynedd
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United Kingdom
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Huddersfield
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United Kingdom
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Ipswich
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United Kingdom
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Lancaster
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United Kingdom
State/province [546] 0 0
Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Maidstone
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Northwood
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
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Plymouth
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United Kingdom
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Poole
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United Kingdom
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Portsmouth
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United Kingdom
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Preston
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United Kingdom
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Prittlewell Chase
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United Kingdom
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Romford
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United Kingdom
State/province [561] 0 0
Sheffield
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United Kingdom
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Shrewsbury
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United Kingdom
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St Helens
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United Kingdom
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Stoke on Trent
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United Kingdom
State/province [565] 0 0
Sutton
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United Kingdom
State/province [566] 0 0
Swansea
Country [567] 0 0
United Kingdom
State/province [567] 0 0
Worthing

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
North Central Cancer Treatment Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Cancer Institute (NCI)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Breast International Group
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Canadian Cancer Trials Group
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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

Data sharing statement


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/NCT00490139