Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT) (COMPACT)
9 de noviembre de 2012 actualizado por: AstraZeneca
Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy
Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program.
Treatment should follow local therapy guidelines and standard practice.
Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Descripción detallada
The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C).
Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Actual)
Inscripción
2313
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Aachen, Alemania
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Aalen, Alemania
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Ahaus, Alemania
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Albstadt, Alemania
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Altotting, Alemania
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Alzey, Alemania
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Amberg, Alemania
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Apolda, Alemania
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Aschaffenburg, Alemania
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Aschersleben, Alemania
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Augsburg, Alemania
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Aurich, Alemania
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Babenhausen, Alemania
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Bad Durkheim, Alemania
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Bad Herrenalb, Alemania
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Bad Nauheim, Alemania
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Bad Neuenahr-Ahrweiler, Alemania
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Bad Oeynhausen, Alemania
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Bad Oldesloe, Alemania
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Bad Reichenhall, Alemania
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Bad Saarow, Alemania
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Bad Segeberg, Alemania
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Bad Tolz, Alemania
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Bad Urach, Alemania
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Bad Wildbad, Alemania
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Bad Wildungen, Alemania
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Bad Windsheim, Alemania
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Baden-Baden, Alemania
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Bamberg, Alemania
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Bautzen, Alemania
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Bayreuth, Alemania
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Berlin, Alemania
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Berlin-Kreuzberg, Alemania
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Berlin-Steglitz, Alemania
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Bexbach, Alemania
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Biberach, Alemania
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Biedenkopf, Alemania
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Bielefeld, Alemania
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Bietigheim-Bissingen, Alemania
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Blankenburg, Alemania
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Blumberg in Baden, Alemania
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Boblingen, Alemania
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Bocholt, Alemania
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Bochum, Alemania
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Bonn, Alemania
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Borna, Alemania
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Bottrop, Alemania
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Brackenheim, Alemania
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Bramsche, Alemania
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Brandenburg, Alemania
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Braunschweig, Alemania
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Bretten, Alemania
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Bruchsal, Alemania
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Bruhl, Alemania
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Buhl, Alemania
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Bunde, Alemania
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Burg, Alemania
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Burghausen, Alemania
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Celle, Alemania
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Chemnitz, Alemania
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Cloppenburg, Alemania
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Coburg, Alemania
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Coesfeld, Alemania
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Dachau, Alemania
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Damme, Alemania
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Datteln, Alemania
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Demmin, Alemania
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Dessau, Alemania
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Dessau-Rosslau, Alemania
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Diessen, Alemania
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Dillenburg, Alemania
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Dillingen, Alemania
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Dinkelsbuhl, Alemania
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Ditzingen, Alemania
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Doberlug-Kirchhain, Alemania
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Dornstadt, Alemania
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Dorsten, Alemania
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Dortmund, Alemania
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Dreieich, Alemania
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Dresden, Alemania
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Duisburg, Alemania
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Duren, Alemania
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Dusseldorf, Alemania
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Ebermannstadt, Alemania
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Ebersbach, Alemania
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Eggenfelden, Alemania
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Eisenach, Alemania
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Ellwangen, Alemania
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Elmshorn, Alemania
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Emmendingen, Alemania
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Erding, Alemania
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Erfurt, Alemania
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Ergolding, Alemania
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Erkelenz, Alemania
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Eschweiler, Alemania
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Esens, Alemania
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Essen, Alemania
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Ettlingen, Alemania
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Euskirchen, Alemania
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Eutin, Alemania
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Feuchtwangen, Alemania
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Flensburg, Alemania
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Frankenberg, Alemania
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Frankenthal, Alemania
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Frankfurt (Oder), Alemania
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Frechen, Alemania
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Freiburg, Alemania
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Freising, Alemania
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Freital, Alemania
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Freyung, Alemania
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Friedrichshafen, Alemania
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Fulda, Alemania
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Furstenfeldbruck, Alemania
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Furstenwalde, Alemania
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Furth, Alemania
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Garbsen, Alemania
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Geesthacht, Alemania
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Geilenkirchen, Alemania
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Gelsenkirchen, Alemania
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Georgsmarienhutte, Alemania
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Gera, Alemania
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Geretsried, Alemania
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Gerlingen, Alemania
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Gersthofen, Alemania
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Giesen, Alemania
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Gifhorn, Alemania
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Gladbeck, Alemania
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Goppingen, Alemania
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Goslar, Alemania
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Gottingen, Alemania
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Grafelfing, Alemania
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Griesheim, Alemania
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Gummersbach, Alemania
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Gunzburg, Alemania
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Gustrow, Alemania
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Haiger, Alemania
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Halberstadt, Alemania
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Halle, Alemania
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Halle / Saale, Alemania
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Hamburg, Alemania
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Hameln, Alemania
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Hamm, Alemania
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Hannover, Alemania
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Hartha, Alemania
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Heide, Alemania
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Heidelberg, Alemania
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Heidenheim, Alemania
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Heilbronn, Alemania
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Heinsberg, Alemania
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Hemmingen, Alemania
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Henstedt-Ulzburg, Alemania
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Heppenheim, Alemania
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Herborn, Alemania
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Herbrechtingen, Alemania
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Herdecke, Alemania
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Herford, Alemania
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Hermsdorf, Alemania
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Herne, Alemania
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Herzberg, Alemania
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Herzberg am Harz, Alemania
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Hessisch Oldendorf, Alemania
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Hilchenbach, Alemania
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Hildesheim, Alemania
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Hillesheim, Alemania
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Hochstadt, Alemania
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Hof, Alemania
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Hofheim, Alemania
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Holzminden, Alemania
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Homburg/Saar, Alemania
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Huckelhoven, Alemania
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Ilsede, Alemania
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Ingolstadt, Alemania
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Isny, Alemania
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Itzehoe, Alemania
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Jena, Alemania
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Kahla, Alemania
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Kalkar, Alemania
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Karlsbad, Alemania
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Karlsruhe, Alemania
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Kassel, Alemania
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Kaufbeuren, Alemania
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Kempten, Alemania
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Kerpen, Alemania
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Kiel, Alemania
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Koblenz, Alemania
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Koln, Alemania
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Konigs Wusterhausen, Alemania
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Konstanz, Alemania
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Korntal-Munchingen, Alemania
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Krefeld, Alemania
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Kreuztal, Alemania
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Krumbach, Alemania
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Kunzelsau, Alemania
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Kusel, Alemania
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Laatzen, Alemania
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Lahnstein, Alemania
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Landau, Alemania
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Landshut, Alemania
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Langen, Alemania
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Langenhagen, Alemania
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Lauf, Alemania
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Lehrte, Alemania
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Leichlingen, Alemania
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Leipzig, Alemania
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Leisnig, Alemania
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Leonberg, Alemania
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Leverkusen, Alemania
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Lich, Alemania
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Limburg, Alemania
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Lingen, Alemania
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Lobau, Alemania
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Lohsa OT Weisskollm, Alemania
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Lubeck, Alemania
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Ludwigsfelde, Alemania
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Ludwigshafen, Alemania
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Luneburg, Alemania
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Lunen, Alemania
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Magdeburg, Alemania
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Mannheim, Alemania
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Marburg, Alemania
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Marienheide, Alemania
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Markranstadt, Alemania
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Marktredwitz, Alemania
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Marl, Alemania
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Mayen, Alemania
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Meiningen, Alemania
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Meissen, Alemania
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Memmingen, Alemania
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Mendig, Alemania
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Mettingen, Alemania
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Metzingen, Alemania
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Minden, Alemania
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Mittweida, Alemania
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Moers, Alemania
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Monchengladbach, Alemania
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Muhldorf, Alemania
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Muhlhausen, Alemania
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Muhlheim, Alemania
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Mulheim a. d. Ruhr, Alemania
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Munchen, Alemania
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Munster, Alemania
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Mutlangen, Alemania
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Nauen, Alemania
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Naunhof, Alemania
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Neckarsulm, Alemania
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Netphen, Alemania
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Neubrandenburg, Alemania
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Neuhaus am Rennweg, Alemania
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Neumarkt, Alemania
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Neumunster, Alemania
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Neuruppin, Alemania
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Neustadt, Alemania
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Neustadt an der Weinstrasse, Alemania
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Nienburg, Alemania
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Nordhausen, Alemania
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Nordhorn, Alemania
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Numbrecht, Alemania
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Nurnberg, Alemania
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Nurtingen, Alemania
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Oberhausen, Alemania
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Oberstdorf, Alemania
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Ochsenfurt, Alemania
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Offenbach, Alemania
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Offenburg, Alemania
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Oranienburg, Alemania
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Osnabruck, Alemania
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Paderborn, Alemania
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Parchim, Alemania
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Passau, Alemania
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Peine, Alemania
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Penzberg, Alemania
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Pfinztal, Alemania
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Pforzheim, Alemania
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Pfullingen, Alemania
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Pinneberg, Alemania
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Pirmasens, Alemania
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Plauen-Kauschwitz, Alemania
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Pocking, Alemania
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Potsdam, Alemania
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Quickborn, Alemania
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Rahden, Alemania
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Rangsdorf, Alemania
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Ravensburg, Alemania
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Recklinghausen, Alemania
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Regensburg, Alemania
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Reinbek, Alemania
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Remchingen, Alemania
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Remscheid, Alemania
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Rendsburg, Alemania
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Reutlingen, Alemania
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Rheine, Alemania
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Rheinfelden, Alemania
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Riebnitz-Damgarten, Alemania
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Riesa, Alemania
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Rodewisch, Alemania
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Rodgau, Alemania
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Rosenheim, Alemania
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Rosrath, Alemania
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Rotenburg, Alemania
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Rottenburg, Alemania
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Rottweil, Alemania
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Saarbrucken, Alemania
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Saarlouis, Alemania
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Salzgitter, Alemania
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Salzwedel, Alemania
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Sandhausen, Alemania
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Sayda, Alemania
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Schalksmuhle, Alemania
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Scheibenberg, Alemania
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Schkeuditz, Alemania
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Schleswig, Alemania
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Schonaich, Alemania
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Schonebeck, Alemania
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Schorndorf, Alemania
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Schwabach, Alemania
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Schwabisch Hall, Alemania
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Schwandorf, Alemania
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Schweinfurt, Alemania
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Schwerin, Alemania
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Schwerte, Alemania
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Schwetzingen, Alemania
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Sebnitz, Alemania
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Senden, Alemania
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Siegen, Alemania
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Simmern, Alemania
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Singen (Hohentwiel), Alemania
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Sogel, Alemania
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Solingen, Alemania
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Sommerda, Alemania
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Spremberg, Alemania
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Sprockhovel, Alemania
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St. Wendel, Alemania
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Starnberg, Alemania
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Stendal, Alemania
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Stockelsdorf, Alemania
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Stralsund, Alemania
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Stuhr, Alemania
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Stuttgart, Alemania
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Sulzbach-Rosenberg, Alemania
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Teltow, Alemania
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Tettnang, Alemania
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Torgau, Alemania
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Tornesch, Alemania
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Tubingen, Alemania
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Uelzen, Alemania
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Uetze, Alemania
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Ulm, Alemania
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Vechta, Alemania
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Vechta-Langforden, Alemania
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Veitshochheim, Alemania
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Viersen, Alemania
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Villingen-Schwenningen, Alemania
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Vilsbiburg, Alemania
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Vlotho, Alemania
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Vohringen, Alemania
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Volklingen, Alemania
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Waldmunchen, Alemania
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Walsrode, Alemania
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Wangen, Alemania
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Warburg, Alemania
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Warendorf, Alemania
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Warin, Alemania
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Wasserburg, Alemania
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Weiden in der Oberpfalz, Alemania
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Weingarten, Alemania
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Wermelskirchen, Alemania
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Werneck, Alemania
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Wertheim, Alemania
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Wetzlar, Alemania
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Wiesbaden, Alemania
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Wilster, Alemania
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Wismar, Alemania
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Witten, Alemania
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Witterda, Alemania
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Wolfen, Alemania
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Wolfsburg, Alemania
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Worms, Alemania
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Wuppertal, Alemania
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Wurselen, Alemania
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Wurzburg, Alemania
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Zittau, Alemania
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Zossen, Alemania
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Zwickau, Alemania
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Zwiesel, Alemania
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Zwonitz, Alemania
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra de probabilidad
Población de estudio
The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C).
Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.
Descripción
Inclusion Criteria:
- Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
- Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
- Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
- In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.
Exclusion Criteria:
- Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
- Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
- Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
- Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
1
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
|---|
|
All patients
treated with Anastrozole as per SPC
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores.
Periodo de tiempo: 12 months
|
12 months
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Incidence of arthralgia and arthralgia characteristics within the 1st year of anastrozole therapy stratified by upfront and switch therapy and assessment of the relationship of arthralgia incidence and arthralgia characteristics to patients compliance.
Periodo de tiempo: 12 months
|
12 months
|
|
Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.
Periodo de tiempo: 12 months
|
12 months
|
|
Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.
Periodo de tiempo: 12 months
|
12 months
|
|
Identification of factors influencing and correlating to treatment-emergent arthralgias
Periodo de tiempo: 12 months
|
12 months
|
|
Assessment of safety and tolerability of anastrozole.
Periodo de tiempo: 12 months
|
12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: H Brasch, AstraZeneca, Germany
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
1 de abril de 2009
Finalización del estudio (Actual)
Finalización del estudio
1 de febrero de 2012
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
5 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
5 de marzo de 2009
Publicado por primera vez (Estimar)
Publicado por primera vez
6 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
12 de noviembre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
9 de noviembre de 2012
Última verificación
Última verificación
1 de noviembre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- NIS-ODE-ARI-2008/1
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