Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

NCT00038467 | Completed Phase 3 Results DMC

• 2 other identifiers: 96-OEXE-031A5991012
• Study Type: interventional
• Target: 4,740
• Locations: 34 countries
• Sites: 373

Brief Summary

To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study

  DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.

  Baseline up to Month 36

Secondary Outcomes (27)

• Overall Survival (OS) at Month 36 Post-Randomization: Main Study

  Baseline up to Month 120

• Number of Events of Second Breast Cancer in Contralateral Breast: Main Study

  Baseline up to Month 120

• Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study

  Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment

• Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study

  Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment

• Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study

  Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment

Study Arms (2)

B

ACTIVE COMPARATOR

Drug: Tamoxifen

A

EXPERIMENTAL

Drug: Exemestane

Interventions

Tamoxifen DRUG

Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

B

Exemestane DRUG

Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

A

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

You may not qualify if:

• unresectable breast cancer
• ER negative primary tumor

Sponsors & Collaborators

• Pfizer: lead
• International Collaborative Cancer Group: collaborator

Study Sites (377)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35213, United States

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Birmingham, Alabama, 35235, United States

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Green Valley, Arizona, 85614, United States

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Green Velley, Arizona, 85614, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85715, United States

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Tucson, Arizona, 85745, United States

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Boulder, Colorado, 80304, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80218, United States

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Fort Collins, Colorado, 80528, United States

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Lakewood, Colorado, 80228, United States

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Thornton, Colorado, 80260, United States

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Jacksonville, Florida, 32204, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville Beach, Florida, 32250, United States

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Ocala, Florida, 34474, United States

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Orange Park, Florida, 32073, United States

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Fishers, Indiana, 46037, United States

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Fishers, Indiana, 46038, United States

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Indianapolis, Indiana, 46219, United States

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Indianapolis, Indiana, 46227, United States

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Indianapolis, Indiana, IN 46219, United States

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Cedar Rapids, Iowa, 52403, United States

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Pittsfield, Massachusetts, 01201, United States

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Albany, New York, 12206, United States

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Latham, New York, 12110-0610, United States

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Portland, Oregon, 97225, United States

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Portland, Oregon, 97227, United States

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Arlington, Texas, 76014-2084, United States

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Bedford, Texas, 76022, United States

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Dallas, Texas, 75230-2510, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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El Paso, Texas, 79902, United States

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El Paso, Texas, 79915, United States

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Garland, Texas, 75042, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77029, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77074, United States

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Longview, Texas, 75601, United States

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McAllen, Texas, 78503, United States

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Mesquite, Texas, 75150, United States

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Odessa, Texas, 79761, United States

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Pasadena, Texas, 77502, United States

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Plano, Texas, 75075-7787, United States

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San Antonio, Texas, 78217, United States

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Sherman, Texas, 75090, United States

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Sugar Land, Texas, 77479, United States

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Tyler, Texas, 75702, United States

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Weslaco, Texas, 78596, United States

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Spokane, Washington, 99202, United States

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Spokane, Washington, 99218, United States

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Haedo, Buenos Aires, 1706, Argentina

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San Isidro, Buenos Aires, 1642, Argentina

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San Martín, Buenos Aires, 1650, Argentina

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Buenos Aires, Buenos Aires F.D., 1406, Argentina

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Buenos Aires, Buenos Aires F.D., 1417, Argentina

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Buenos Aires, Buenos Aires F.D., 1425, Argentina

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Buenos Aires, Buenos Aires F.D., 1426, Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Rosario, Pcia. de Santa Fe, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Buenos Aires, 1181, Argentina

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Córdoba, X5000AA1, Argentina

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Camperdown, New South Wales, 2050, Australia

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Dubbo, New South Wales, 2830, Australia

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Liverpool, New South Wales, 2170, Australia

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Waratah, New South Wales, 2298, Australia

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Adelaide, South Australia, 5000, Australia

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Bendigo, Victoria, 3552, Australia

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Box Hill, Victoria, 3128, Australia

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Ringwood East, Victoria, 3135, Australia

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Antwerp, 2020, Belgium

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Arlon, 6700, Belgium

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Baudour, 7331, Belgium

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Brasschaat, 2930, Belgium

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Brussels, 1000, Belgium

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Brussels, 1180, Belgium

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Charleroi, 6000, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Haine-Saint-Paul, 7100, Belgium

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Hasselt, 3500, Belgium

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Kraainem, 1950, Belgium

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La Louvière, 7100, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Merksem, 2170, Belgium

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Namur, 5000, Belgium

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Verviers, 4800, Belgium

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Wilrijk, 2610, Belgium

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Sarajevo, 71000, Bosnia and Herzegovina

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Plovdiv, 4004, Bulgaria

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Sofia, 1504, Bulgaria

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Sofia, 1756, Bulgaria

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Sofia, 1784, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Osijek, Croatia

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Split, Croatia

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Zagreb, 10000, Croatia

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Zagreb, Croatia

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Brno, 656 53, Czechia

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České Budějovice, 370 87, Czechia

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Prague, 12808, Czechia

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Aarhus C, 8000, Denmark

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Esbjerg, 6700, Denmark

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Herlev, 2730, Denmark

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Herning, 7400, Denmark

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Hilleroed, 3400, Denmark

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Koebenhavn OE, 2100, Denmark

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Næstved, 4700, Denmark

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Roskilde, 4000, Denmark

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Vejle, 7100, Denmark

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Viborg, 8800, Denmark

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Cairo, Egypt

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Tartu, 51014, Estonia

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Bordeaux, France, 33030 Cedex, France

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Bordeaux, France, 33300 Cedex, France

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Angers, 49033 Cedex 01, France

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Annecy, 74011, France

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Avignon, 84082, France

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Brest, 29609 Cedex, France

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Caen, 14052 Cedex, France

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Caen, 14076, France

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Clermont-Ferrand, 63011, France

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Évreux, 27000, France

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Lagny-sur-Marne, 77405 Cedex, France

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Le Havre, 76600, France

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Le Mans, 72000, France

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Lille, 59020 Cedex, France

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Lyon, 69373, France

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Marseille, 13273, France

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Meaux, 77100, France

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Montbéliard, 25209 Cedex, France

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Mulhouse, 68070 Cedex, France

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Nice, 06189, France

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Paris, 75248 Cedex 5, France

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Paris, 75970 Cedex 20, France

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Perpignan, 66046, France

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Rennes, 35042, France

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Rouen, 76038 Cedex, France

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Saint-Cloud, 92210, France

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Saint-Herblain, 44805, France

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Strasbourg, 67091 Cedex, France

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Toulouse, 31502, France

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Berlin, 10117, Germany

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Berlin, 13353, Germany

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Chemnitz, 09126, Germany

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Erlangen, 91054, Germany

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Freiburg im Breisgau, 79106, Germany

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Gera, 07548, Germany

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Greiz, 07973, Germany

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Halle, 06110, Germany

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Halle, 06120, Germany

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Hamburg, 22081, Germany

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Hildburghausen, 98646, Germany

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Leipzig, 04129, Germany

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Lübeck, 23538, Germany

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München, 80335, Germany

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Riesa, 01589, Germany

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Rodewisch, 08228, Germany

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Saarbrücken, 66113, Germany

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Suhl, 98527, Germany

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Weiden, 92637, Germany

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Athens, Attica, 115 22, Greece

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Athens, Attica, 115 28, Greece

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Heraklion, Crete, 71 110, Greece

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New Territories, Hong Kong

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Budapest, 1082, Hungary

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Budapest, 1122, Hungary

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Budapest, 1145, Hungary

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Cork, Ireland

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Cork, Ireland, Ireland

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Dublin, Ireland

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Galway, Ireland

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Haifa, 34362, Israel

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Haifa, Israel

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Jerusalem, 91120, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Rehovot, Israel

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Carpi, Modena, 41012, Italy

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Alba (CN), 12051, Italy

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Aviano (PN), 33081, Italy

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Bergamo, 24128, Italy

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Biella, 13900, Italy

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Cagliari, 09121, Italy

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Casale Monferrato, AL, 15033, Italy

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Correggio, 42015, Italy

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Cremona, 26100, Italy

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Cuneo, 12100, Italy

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Fermo FM, 63023, Italy

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Florence, 50134, Italy

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Genova, 16128, Italy

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Genova, 16132, Italy

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Lecco, 23900, Italy

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Lodi, 20075, Italy

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Mantova, 46100, Italy

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Milan, 20121, Italy

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Milan, 20133, Italy

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Milan, 20141, Italy

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Milan, 21053, Italy

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Modena, 41100, Italy

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Monserrato (CA), 09042, Italy

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Monza, 20052, Italy

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Napoli, 80131, Italy

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Palermo, 90139, Italy

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Parma, 43100, Italy

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Perugia, 06132, Italy

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Piacenza, 29100, Italy

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Pietra Ligure (SV), 17027, Italy

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Pisa, 56100, Italy

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Reggio Emilia, 42100, Italy

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Roma, 00148, Italy

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Sassari, 07100, Italy

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Terni, 05100, Italy

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Thiene (VI), 36016, Italy

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Torino, 10126, Italy

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Tortona, 15057, Italy

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Trescore Balneario BG, 24069, Italy

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Treviglio (BG), 24047, Italy

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Varese, 21100, Italy

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Luxembourg, 1210, Luxembourg

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Floriana, VLT 14, Malta

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Amersfoort, 3818 ES, Netherlands

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Amsterdam, 1061 AE, Netherlands

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Amsterdam, 1066 CX, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Apeldoorn, 7300 DS, Netherlands

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Blaricum, 1261 AN, Netherlands

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Breda, 4818 CK, Netherlands

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Delft, 2625 AD, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Enschede, 7513 ER, Netherlands

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Groningen, 9700 RM, Netherlands

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Groningen, 9728 NZ, Netherlands

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Hengelo, 7555 DL, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Leiden, 2333 ZA, Netherlands

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Leidschendam, 2262 BA, Netherlands

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Podybus 90153, 5200 ME Den Bosch, Netherlands

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Roermond, 6043 CV, Netherlands

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Sittard, 6131 BK, Netherlands

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The Hague, 2545 CH, Netherlands

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Utrecht, 3582 KE, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Zaandam, 1502 DV, Netherlands

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Hamilton, Waikato Region, 2021, New Zealand

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Auckland, 1142, New Zealand

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Bergen, 5021, Norway

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Bodø, 8092, Norway

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Fredrikstad, 1603, Norway

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Haugesund, 5390, Norway

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Levanger, 7600, Norway

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Mo i Rana, 8607, Norway

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Molde, 6407, Norway

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Notodden, 3674, Norway

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Oslo, Norway

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Rissa, 7100, Norway

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Rjukan, 3660, Norway

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Sandefjord, Norway

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Tromsø, 9038, Norway

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Tønsberg, 3103, Norway

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Lima, Lima Province, L34, Peru

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Gdansk, 80-952, Poland

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Gliwice, 44-101, Poland

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Krakow, 31-115, Poland

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Krakow, 31-826, Poland

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Lodz, 93-509, Poland

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Opole, 45-060, Poland

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Poznan, 61-878, Poland

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Sopot, 81-756, Poland

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Warsaw, 02-781, Poland

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Coimbra, 3040, Portugal

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Coimbra, Portugal

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Evora, 7000-811, Portugal

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Bucharest, 72435, Romania

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Cluj-Napoca, 400015, Romania

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Timișoara, 300223, Romania

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Saint Petersburg, 197758, Russia

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Kamenitz, Serbia, 21204, Serbia

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Belgrade, 11000, Serbia

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Banská Bystrica, 97517, Slovakia

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Bratislava, SK-83310, Slovakia

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Košice, 041 90, Slovakia

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Ljubljana, 1000, Slovenia

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Johannesburg, Gauteng, 2196, South Africa

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Observatory, 7925, South Africa

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Albacete, Albacete, 02006, Spain

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Alcoy, Alicante, 03804, Spain

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Alicante, Alicante, 03010, Spain

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Elche, Alicante, 03203, Spain

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Sant Joan d'Alacant, Alicante, 03550, Spain

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Badajoz, Badajoz, 06008, Spain

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Badajoz, Badajoz, 06080, Spain

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Badalona, Barcelona, 08911, Spain

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Badalona, Barcelona, 08916, Spain

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Terrassa, Barcelona, 08221, Spain

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Terrassa, Barcelona, 08227, Spain

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Córdoba, Cordoba, 14004, Spain

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Guadalajara, Guadalajara, 19002, Spain

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Donostia / San Sebastian, Guipuzcoa, 20014, Spain

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Barbastro, Huesca, 22300, Spain

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Lleida, Lleida, 25198, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28041, Spain

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Reus, Tarragona, 43201, Spain

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Valencia, Valencia, 46014, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Borås, Sweden, 50182, Sweden

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Borås, 501 82, Sweden

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Gothenburg, 413 45, Sweden

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Halmstad, 301 85, Sweden

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Helsingborg, 251 87, Sweden

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Kristianstad, 291 85, Sweden

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Linköping, 581 85, Sweden

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Lund, 221 85, Sweden

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Malmo, 205 02, Sweden

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Motala, 591 85, Sweden

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Nässjö, 575 81, Sweden

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Norrköping, 601 82, Sweden

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Vaxjo, 351 85, Sweden

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Värnamo, 331 85, Sweden

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Västerås, 721 89, Sweden

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Västervik, 59381, Sweden

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Basel, CH-4031, Switzerland

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Bellinzona, CH-6500, Switzerland

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Bern, 3010, Switzerland

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Bern, CH-3012, Switzerland

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Geneva, CH-1211, Switzerland

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Huntingdon, Cambs, PE18 8NT, United Kingdom

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Bournemouth, Dorset, BH7 7DW, United Kingdom

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Hull, East Yorkshire, HU16 5JQ, United Kingdom

Location

Pfizer Investigational Site

Epping, Essex, CM166TN, United Kingdom

Location

Pfizer Investigational Site

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

Location

Pfizer Investigational Site

Newport, Gwent, NP6 2UB, United Kingdom

Location

Pfizer Investigational Site

Bangor, Gwynedd, LL57 2PW, United Kingdom

Location

Pfizer Investigational Site

Salterhebble, Halifax, HX6 0PW, United Kingdom

Location

Pfizer Investigational Site

Gosport, Hants, PO12 2AA, United Kingdom

Location

Pfizer Investigational Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Pfizer Investigational Site

Harrogate, N. Yorkshire, HG2 7SX, United Kingdom

Location

Pfizer Investigational Site

Londonderry, Northern Ireland, BT47 1SB, United Kingdom

Location

Pfizer Investigational Site

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Pfizer Investigational Site

Swansea, South Wales, SA2 8QA, United Kingdom

Location

Pfizer Investigational Site

York, Yorkshire, Y03 7He, United Kingdom

Location

Pfizer Investigational Site

Belfast, BT97AB, United Kingdom

Location

Pfizer Investigational Site

Bradford, BD9 6RJ, United Kingdom

Location

Pfizer Investigational Site

Bristol, BS10 5NB, United Kingdom

Location

Pfizer Investigational Site

Cardiff, CF14 2TL, United Kingdom

Location

Pfizer Investigational Site

Coventry, CV2 2DX, United Kingdom

Location

Pfizer Investigational Site

East Kilbride, G75 8RG, United Kingdom

Location

Pfizer Investigational Site

Huddersfield, HD3 3EA, United Kingdom

Location

Pfizer Investigational Site

Leeds, LS1 3EX, United Kingdom

Location

Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Pfizer Investigational Site

Lincoln, United Kingdom

Location

Pfizer Investigational Site

London, N18 1QX, United Kingdom

Location

Pfizer Investigational Site

London, N19 5NF, United Kingdom

Location

Pfizer Investigational Site

London, NW3 2QG, United Kingdom

Location

Pfizer Investigational Site

London, SW17 0QT, United Kingdom

Location

Pfizer Investigational Site

London, W6 8RF, United Kingdom

Location

Pfizer Investigational Site

Luton, LU4 0DZ, United Kingdom

Location

Pfizer Investigational Site

Manchester, M20 4BX, United Kingdom

Location

Pfizer Investigational Site

Sheffield, S10 2SJ, United Kingdom

Location

Pfizer Investigational Site

Shrewsbury, United Kingdom

Location

Pfizer Investigational Site

Somerset, BA21 4AT, United Kingdom

Location

Pfizer Investigational Site

Southampton, S016 6YD, United Kingdom

Location

Pfizer Investigational Site

Steeton, BD20 6TD, United Kingdom

Location

Pfizer Investigational Site

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Pfizer Investigational Site

Telford, TF1 6TF, United Kingdom

Location

Pfizer Investigational Site

Wythenshawe, Manchester, M23 9LT, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Other AEs included both SAEs and AEs. Non-SAE could not be presented separately for this study as AEs were collected in clinical database where SAE flags were not collected.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2002
• First Posted: June 3, 2002
• Study Start: February 1, 1998
• Primary Completion: June 1, 2003
• Study Completion: March 1, 2013
• Last Updated: May 7, 2014
• Results First Posted: April 10, 2014

Record last verified: 2014-04

Locations

SL (3); CR (4); US (57); IE (4); LU (1); NL (23); NZ (2); PT (3); RU (1); DE (19); DK (10); GB (40); CZ (3); IT (41); IL (7); PE (1); AU (8); AR (12); BO (1); GR (3); HK (1); ES (22); PL (9); SE (16); CH (5); HU (3); BU (5); BE (19); MA (1); NO (14); FR (29); ZA (2); EG (1); RO (3)