A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer
1 other identifier
interventional
2,296
33 countries
434
Brief Summary
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Sep 2006
Typical duration for phase_3 breast-cancer
434 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 16, 2007
CompletedFirst Posted
Study publicly available on registry
March 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
May 25, 2015
CompletedMay 25, 2015
May 1, 2015
6.4 years
March 16, 2007
December 22, 2014
May 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)
Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.
Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion
Secondary Outcomes (5)
Percentage of Participants With Disease Progression
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Time to Progression (TTP)
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Percentage of Participants With Recorded Death
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Overall Survival
Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months
Percentage of Participants by Best Overall Response to Treatment
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Study Arms (1)
1
EXPERIMENTALInterventions
10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
Eligibility Criteria
You may qualify if:
- patients, \>=18 years of age;
- HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
- candidates for chemotherapy.
You may not qualify if:
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- concomitant hormonal therapy for metastatic or locally recurrent disease;
- concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
- previous radiotherapy for treatment of metastatic disease;
- evidence of CNS metastases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (457)
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Buenos Aires, 1406, Argentina
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Buenos Aires, 1878, Argentina
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La Plata, B1902CMK, Argentina
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Rosario, S2002KDS, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Adelaide, 5000, Australia
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Darlinghurst, 2010, Australia
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East Melbourne, 3002, Australia
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Frankston, 3199, Australia
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Gosford, 2250, Australia
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Lismore, 2480, Australia
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Maroochydore, 4558, Australia
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Milton, 4064, Australia
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Perth, 6000, Australia
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Richmond, 3121, Australia
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St Leonards, 2065, Australia
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Sydney, 2031, Australia
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Sydney, 2060, Australia
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Wodonga, 3690, Australia
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Bludesch, 6712, Austria
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Bregenz, 6900, Austria
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Dornbirn, 6850, Austria
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Graz, 8036, Austria
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Hall in Tirol, 6060, Austria
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Innsbruck, 6020, Austria
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Klagenfurt, 9026, Austria
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Krems, 3500, Austria
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Kufstein, 6330, Austria
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Leoben, 8700, Austria
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Linz, 4010, Austria
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Ried-innkreis, 4910, Austria
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Sankt Pölten, 3100, Austria
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Sankt Veit an der Glan, 9300, Austria
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Steyr, 4400, Austria
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Vienna, 1030, Austria
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Vienna, 1130, Austria
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Vienna, 1140, Austria
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Vienna, 1160, Austria
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Vienna, 1220, Austria
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Villach, 9500, Austria
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Wels, 4600, Austria
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Wiener Neustadt, 2700, Austria
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Zams, 6511, Austria
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Belo Horizonte, 30140-083, Brazil
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Belo Horizonte, 30150-221, Brazil
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Belo Horizonte, 30150-320, Brazil
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Campinas, 13060-803, Brazil
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Campinas, 13073-400, Brazil
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Curitiba, 80530-010, Brazil
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Curitiba, 80730-180, Brazil
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Fortaleza, 60125-151, Brazil
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Fortaleza, 60741-420, Brazil
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Goiânia, 74075-040, Brazil
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Ijuí, 98700-000, Brazil
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Jaú, 17210-080, Brazil
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João Pessoa, 58040280, Brazil
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Niterói, 24220-007, Brazil
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Piracicaba, 13419-155, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 91430-001, Brazil
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Porto Alegre, Brazil
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Recife, 52012-220, Brazil
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Ribeirão Preto, 14025-430, Brazil
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Rio de Janeiro, 21941-590, Brazil
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Rio de Janeiro, 22031072, Brazil
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Rio de Janeiro, 22631-004, Brazil
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Salvador, 41950-610, Brazil
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Santos, 11075-350, Brazil
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São Paulo, 01232-010, Brazil
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São Paulo, 01308-000, Brazil
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São Paulo, 01308-050, Brazil
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São Paulo, 01332-000, Brazil
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São Paulo, 01406100, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 03102-002, Brazil
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São Paulo, 05403-010, Brazil
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São Paulo, 08270-070, Brazil
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Sorocaba, 18035-300, Brazil
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Vitória, 29055-270, Brazil
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Plovdiv, 4004, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1784, Bulgaria
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Varna, 9010, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Surrey, British Columbia, V3V 1Z2, Canada
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Barrie, Ontario, L4M 6MZ, Canada
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Brampton, Ontario, L6R 3J7, Canada
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East York, Ontario, M4C 3E7, Canada
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Mississauga, Ontario, L5M 2N1, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Sault Ste. Marie, Ontario, P6A 2C4, Canada
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Scarborough Village, Ontario, M1P 2V5, Canada
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St. Catharines, Ontario, L2R 7C6, Canada
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Toronto, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Toronto, Ontario, M9C 1A5, Canada
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Windsor, Ontario, N8W 2X3, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Québec, Quebec, G1S 4L8, Canada
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Regina, Saskatchewan, S4T 7T1, Canada
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Beijing, 100021, China
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Beijing, 100071, China
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Changchun, 130012, China
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Changsha, 410006, China
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Chengdu, 610041, China
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Chongqing, 400038, China
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Guangzhou, 510060, China
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Hangzhou, 310022, China
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Hefei, 230022, China
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Nanjing, 210002, China
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Shanghai, 200032, China
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Shanghai, 200080, China
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Suzhou, 215006, China
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Tianjin, 300060, China
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Cali, Colombia
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Neiva, Colombia
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Pereira, Colombia
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Ostrava, 708 52, Czechia
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Prague, 180 81, Czechia
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Quito, EC170125, Ecuador
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Alexandria, 11737, Egypt
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Tallinn, 11619, Estonia
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Tartu, 50406, Estonia
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Hämeenlinna, 13530, Finland
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Kotka, 48210, Finland
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Kuopio, 70211, Finland
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Pori, 28500, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Vaasa, 65130, Finland
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Alès, 30100, France
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Angers, 49933, France
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Avignon, 84918, France
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Bayonne, 64100, France
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Bayonne, 64109, France
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Besançon, 25030, France
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Bobigny, 93009, France
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Bordeaux, 33000, France
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Bordeaux, 33077, France
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Boulogne-Billancourt, 92100, France
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Boulogne-sur-Mer, 62222, France
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Brest, 29609, France
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Chalon-sur-Saône, 71100, France
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Châteauroux, 36019, France
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Clermont-Ferrand, 63023, France
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Colmar, 68024, France
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Créteil, 94010, France
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Dax, 40107, France
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Dijon, 21000, France
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Gap, 05007, France
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Grenoble, 38043, France
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La Chaussée-Saint-Victor, 41260, France
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La Tronche, 38700, France
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Le Chesnay, 78157, France
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Le Coudray, 28630, France
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Le Mans, 72000, France
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Lille, 59000, France
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LIsle-dEspagnac, 16340, France
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Lyon, 69437, France
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Mantes-la-Jolie, 78201, France
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Marseille, 13285, France
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Marseille, 13291, France
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Metz, 57038, France
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Metz, 57072, France
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Mont-de-Marsan, 40024, France
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Montbéliard, 25209, France
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Montfermeil, 93370, France
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Montpellier, 34967, France
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Mougins, 06250, France
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Nancy, 54100, France
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Nevers, 58000, France
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Niort, 79021, France
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Nîmes, 30900, France
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Paris, 75012, France
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Paris, 75231, France
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Paris, 75475, France
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Paris, 75651, France
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Paris, 75908, France
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Paris, 75970, France
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Perpignan, 66000, France
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Périgueux, 24000, France
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Pierre-Bénite, 69310, France
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Pontoise, 95300, France
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Reims, 51056, France
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Rouen, 76038, France
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Saint-Brieuc, 22015, France
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Saint-Cloud, 92210, France
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Saint-denis de La Reunion, 97400, France
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Saint-Grégoire, 35768, France
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Saint-Jean, 31240, France
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Saint-Pierre, 97448, France
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Saint-Priest-en-Jarez, 42271, France
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Strasbourg, 67065, France
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Strasbourg, 67091, France
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Toulon, 83056, France
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Toulouse, 31052, France
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Toulouse, 31078, France
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Tours, 37044, France
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Valenciennes, 59322, France
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Vandœuvre-lès-Nancy, 54511, France
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Vannes, 56001, France
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Villeneuve-sur-Lot, 47307, France
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Augsburg, 86150, Germany
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Bad Saarow, 15526, Germany
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Berlin, 10117, Germany
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Berlin, 13125, Germany
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Berlin, 13589, Germany
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Bielefeld, 33604, Germany
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Bochum, 44787, Germany
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Böblingen, 71032, Germany
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Chemnitz, 09116, Germany
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Cottbus, 03046, Germany
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Deggendorf, 94469, Germany
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Dresden, 01307, Germany
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Duisburg, 47051, Germany
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Düsseldorf, 40479, Germany
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Erfurt, 99085, Germany
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Essen, 45122, Germany
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Frankfurt, 65929, Germany
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Freiburg im Breisgau, 79106, Germany
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Halle, 06120, Germany
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Hamburg, 20249, Germany
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Hamburg, 22081, Germany
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Hanover, 30167, Germany
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Hanover, 30559, Germany
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Kassel, 34117, Germany
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Kiel, 24105, Germany
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Leipzig, 04129, Germany
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Lübeck, 23562, Germany
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Magdeburg, 39108, Germany
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Magdeburg, 39130, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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München, 80638, Germany
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Regensburg, 93053, Germany
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Rostock, 18059, Germany
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Saarbrücken, 66113, Germany
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Stralsund, 18435, Germany
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Stuttgart, 70176, Germany
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Stuttgart, 70199, Germany
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Troisdorf, 53804, Germany
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Ulm, 89075, Germany
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Unna, 59423, Germany
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Wiesbaden, 65199, Germany
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Wuppertal, 42105, Germany
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Würselen, 52146, Germany
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Szeged, 6720, Hungary
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Beersheba, 8410101, Israel
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Haifa, 34354, Israel
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Holon, 58100, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Safed, 13110, Israel
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Tel Aviv, 6423906, Israel
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Ẕerifin, 70300, Israel
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Ancona, Italy
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Aviano, 33081, Italy
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Brescia, 25123, Italy
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Cagliari, 09100, Italy
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Cagliari, 09121, Italy
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Candiolo, 10060, Italy
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Carpi, 41012, Italy
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Castelfranco Veneto, 31033, Italy
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Castrovillari, 87012, Italy
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Catania, 95100, Italy
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Chieti, 66100, Italy
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Como, 22100, Italy
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Cremona, 26100, Italy
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Frattamaggiore, 80027, Italy
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Genova, 16132, Italy
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Lecce, 73100, Italy
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Lido di Camaiore, 55043, Italy
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Lucca, 55100, Italy
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Mantova, 46100, Italy
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Messina, 98123, Italy
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Milan, 20142, Italy
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Milan, 20162, Italy
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Montevarchi, 52025, Italy
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Napoli, 80131, Italy
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Novara, 28100, Italy
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Palermo, 90127, Italy
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Paola, 87027, Italy
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Pavia, 27100, Italy
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Piove di Sacco, 35028, Italy
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Pordenone, 33170, Italy
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Pozzuoli, 80087, Italy
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Prato, 59100, Italy
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Ravenna, 48100, Italy
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Rionero in Vulture, 85028, Italy
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Roma, 00128, Italy
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Roma, 00144, Italy
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Roma, 00153, Italy
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Roma, 00168, Italy
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Roma, 00189, Italy
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Salerno, 84131, Italy
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San Giovanni Rotondo, 71013, Italy
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Saronno, 21047, Italy
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Sassari, 07100, Italy
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Siena, 53100, Italy
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Torino, 10126, Italy
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Verona, 37126, Italy
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Vicenza, 36100, Italy
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Riga, LV 1079, Latvia
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Riga, LV-1002, Latvia
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Beirut, 1107 2020, Lebanon
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Beirut, 166378, Lebanon
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Kaunas, 50009, Lithuania
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Klaipėda, 5808, Lithuania
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Vilnius, 08660, Lithuania
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Chihuahua City, 31000, Mexico
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Ciudad Juárez, 32300, Mexico
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Guadalajara, 45200, Mexico
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León, 37000, Mexico
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Mexico City, 06700, Mexico
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Mexico City, 07360, Mexico
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Mexico City, 14140, Mexico
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Mexico City, 97000, Mexico
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Puebla City, 72240, Mexico
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Tijuana, 22320, Mexico
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Rabat, 10 000, Morocco
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Rabat, 21000, Morocco
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Ac Amsterdam, 1091, Netherlands
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Blaricum, 1261 AN, Netherlands
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Capelle Ad Yssel, 2906 ZC, Netherlands
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Delftzijl, 9934 JD, Netherlands
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Doetinchem, 7009 BL, Netherlands
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Flushing, 4382 EE, Netherlands
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Goes, 4462 RA, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Zoetermeer, 2275 NA, Netherlands
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Bydgoszcz, 85-796, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-226, Poland
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Poznan, 61-866, Poland
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Warsaw, 00-909, Poland
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Warsaw, 02-781, Poland
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Almada, 2801-951, Portugal
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Aveiro, 3814-501, Portugal
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Barreiro, 2830-094, Portugal
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Beja, 7801-849, Portugal
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Cascais, 2750-349, Portugal
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Coimbra, 3000-061, Portugal
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Lisbon, 1150-199, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1998-018, Portugal
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Porto, 4099-001, Portugal
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Porto, 4200-072, Portugal
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Porto, 4200-319, Portugal
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Santa Maria da Feira, 4520-211, Portugal
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Santarém, 2005-177, Portugal
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Setúbal, 2910-446, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Balashikha, 143900, Russia
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Barnaul, 656049, Russia
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Engel's, 413115, Russia
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Izhevsk, 426009, Russia
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Kazan', 420029, Russia
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Kazan', 420111, Russia
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Kursk, 305035, Russia
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Moscow, 107005, Russia
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Moscow, 115478, Russia
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Moscow, 121356, Russia
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Moscow, 125284, Russia
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Moscow, 143423, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Smolensk, 214000, Russia
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Stavropol, 355047, Russia
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Tver', 170008, Russia
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Tyumen, 625047, Russia
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Ufa, 450054, Russia
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Ulyanovsk, ND, Russia
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Yekaterinburg, 620905, Russia
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Jeddah, 21499, Saudi Arabia
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Riyadh, 11211, Saudi Arabia
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Riyadh, 22490, Saudi Arabia
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Banská Bystrica, 975 17, Slovakia
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Bratislava, 812 50, Slovakia
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Bratislava, 831 01, Slovakia
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Košice, 041 90, Slovakia
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Poprad, 05801, Slovakia
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Prešov, 080 01, Slovakia
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Žilina, 012 07, Slovakia
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Ljubljana, 1000, Slovenia
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Alcorcón, 28922, Spain
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Barakaldo, 48903, Spain
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Barcelona, 08029, Spain
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Castellon, 12002, Spain
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Donostia / San Sebastian, 20012, Spain
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Donostia / San Sebastian, 20080, Spain
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Gijón, 33394, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Logroño, 26001, Spain
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Madrid, 28041, Spain
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Madrid, 28905, Spain
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Madrid, 28943, Spain
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Manresa, 08243, Spain
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Murcia, 30008, Spain
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Navarra, 31008, Spain
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Ourense, 32005, Spain
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Palma de Mallorca, 07014, Spain
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Pontevedra, 36002, Spain
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Sabadell, Barcelona, 08208, Spain
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Sagunto, 46520, Spain
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Salamanca, 37007, Spain
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Santiago de Compostela, 15706, Spain
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Terrassa, 08221, Spain
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Terrassa, 08227, Spain
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Valencia, 46026, Spain
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Vigo, 36204, Spain
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Zamora, 49021, Spain
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Gothenburg, 41345, Sweden
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Jönköping, 55185, Sweden
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Kalmar, 39185, Sweden
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Karlstad, 65185, Sweden
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Malmo, 20502, Sweden
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Stockholm, 11486, Sweden
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Sundsvall, 85186, Sweden
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Vaxjo, 35185, Sweden
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Västerås, 72189, Sweden
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Aarau, 5000, Switzerland
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Baden, 5404, Switzerland
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Biel, 2502, Switzerland
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Genolier, 1272, Switzerland
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Locarno, 6601, Switzerland
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Lugano, 6900, Switzerland
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Istanbul, 34300, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Shhiye, Ankara, 06100, Turkey (Türkiye)
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Colchester, CO3 3NB, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Glasgow, G11 6NT, United Kingdom
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London, W6 8RF, United Kingdom
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Peterborough, PE 3 9GZ, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Westcliffe-on-sea, SS0 0RY, United Kingdom
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Worthing, B11 2DH, United Kingdom
Related Publications (2)
Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.
PMID: 25047747DERIVEDXu BH, Jiang ZF, Shen ZZ, Guan ZZ, Chen ZD, Cheng Y, Zheng H, Jiang J, Wang XJ, Tong ZS, Qin SK, Luo Y, Yao M, Wang LW, He J. Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer: findings from the ATHENA study. Chin Med J (Engl). 2012 Mar;125(5):764-9.
PMID: 22490570DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2007
First Posted
March 19, 2007
Study Start
September 1, 2006
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
May 25, 2015
Results First Posted
May 25, 2015
Record last verified: 2015-05