Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT) (COMPACT)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 2313

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
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  • Aalen, Germany
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  • Ahaus, Germany
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  • Albstadt, Germany
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  • Altotting, Germany
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  • Alzey, Germany
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  • Amberg, Germany
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  • Apolda, Germany
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  • Aschaffenburg, Germany
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  • Aschersleben, Germany
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  • Augsburg, Germany
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  • Aurich, Germany
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  • Babenhausen, Germany
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  • Bad Durkheim, Germany
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  • Bad Herrenalb, Germany
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  • Bad Nauheim, Germany
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  • Bad Neuenahr-Ahrweiler, Germany
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  • Bad Oeynhausen, Germany
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  • Bad Oldesloe, Germany
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  • Bad Reichenhall, Germany
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  • Bad Saarow, Germany
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  • Bad Segeberg, Germany
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  • Bad Tolz, Germany
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  • Bad Urach, Germany
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  • Bad Wildbad, Germany
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  • Bad Wildungen, Germany
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  • Bad Windsheim, Germany
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  • Baden-Baden, Germany
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  • Bamberg, Germany
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  • Bautzen, Germany
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  • Bayreuth, Germany
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  • Berlin, Germany
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  • Berlin-Kreuzberg, Germany
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  • Berlin-Steglitz, Germany
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  • Bexbach, Germany
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  • Biberach, Germany
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  • Biedenkopf, Germany
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  • Bielefeld, Germany
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  • Bietigheim-Bissingen, Germany
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  • Blankenburg, Germany
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  • Blumberg in Baden, Germany
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  • Boblingen, Germany
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  • Bocholt, Germany
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  • Bochum, Germany
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  • Bonn, Germany
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  • Borna, Germany
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  • Bottrop, Germany
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  • Brackenheim, Germany
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  • Bramsche, Germany
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  • Brandenburg, Germany
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  • Braunschweig, Germany
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  • Bretten, Germany
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  • Bruchsal, Germany
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  • Bruhl, Germany
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  • Buhl, Germany
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  • Bunde, Germany
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  • Burg, Germany
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  • Burghausen, Germany
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  • Celle, Germany
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  • Chemnitz, Germany
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  • Cloppenburg, Germany
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  • Coburg, Germany
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  • Coesfeld, Germany
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  • Dachau, Germany
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  • Damme, Germany
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  • Datteln, Germany
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  • Demmin, Germany
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  • Dessau, Germany
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  • Dessau-Rosslau, Germany
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  • Diessen, Germany
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  • Dillenburg, Germany
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  • Dillingen, Germany
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  • Dinkelsbuhl, Germany
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  • Ditzingen, Germany
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  • Doberlug-Kirchhain, Germany
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  • Dornstadt, Germany
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  • Dorsten, Germany
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  • Dortmund, Germany
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  • Dreieich, Germany
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  • Dresden, Germany
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  • Duisburg, Germany
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  • Duren, Germany
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  • Dusseldorf, Germany
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  • Ebermannstadt, Germany
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  • Ebersbach, Germany
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  • Eggenfelden, Germany
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  • Eisenach, Germany
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  • Ellwangen, Germany
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  • Elmshorn, Germany
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  • Emmendingen, Germany
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  • Erding, Germany
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  • Erfurt, Germany
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  • Ergolding, Germany
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  • Erkelenz, Germany
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  • Eschweiler, Germany
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  • Esens, Germany
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  • Essen, Germany
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  • Ettlingen, Germany
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  • Euskirchen, Germany
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  • Eutin, Germany
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  • Feuchtwangen, Germany
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  • Flensburg, Germany
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  • Frankenberg, Germany
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  • Frankenthal, Germany
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  • Frankfurt (Oder), Germany
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  • Frechen, Germany
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  • Freiburg, Germany
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  • Freising, Germany
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  • Freital, Germany
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  • Freyung, Germany
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  • Friedrichshafen, Germany
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  • Fulda, Germany
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  • Furstenfeldbruck, Germany
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  • Furstenwalde, Germany
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  • Furth, Germany
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  • Garbsen, Germany
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  • Geesthacht, Germany
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  • Geilenkirchen, Germany
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  • Gelsenkirchen, Germany
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  • Georgsmarienhutte, Germany
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  • Gera, Germany
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  • Geretsried, Germany
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  • Gerlingen, Germany
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  • Gersthofen, Germany
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  • Giesen, Germany
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  • Gifhorn, Germany
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  • Gladbeck, Germany
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  • Goppingen, Germany
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  • Goslar, Germany
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  • Gottingen, Germany
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  • Grafelfing, Germany
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  • Griesheim, Germany
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  • Gummersbach, Germany
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  • Gunzburg, Germany
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  • Gustrow, Germany
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  • Haiger, Germany
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  • Halberstadt, Germany
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  • Halle, Germany
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  • Halle / Saale, Germany
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  • Hamburg, Germany
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  • Hameln, Germany
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  • Hamm, Germany
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  • Hannover, Germany
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  • Hartha, Germany
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  • Heide, Germany
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  • Heidelberg, Germany
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  • Heidenheim, Germany
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  • Heilbronn, Germany
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  • Heinsberg, Germany
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  • Hemmingen, Germany
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  • Henstedt-Ulzburg, Germany
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  • Heppenheim, Germany
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  • Herborn, Germany
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  • Herbrechtingen, Germany
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  • Herdecke, Germany
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  • Herford, Germany
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  • Hermsdorf, Germany
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  • Herne, Germany
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  • Herzberg, Germany
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  • Herzberg am Harz, Germany
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  • Hessisch Oldendorf, Germany
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  • Hilchenbach, Germany
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  • Hildesheim, Germany
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  • Hillesheim, Germany
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  • Hochstadt, Germany
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  • Hof, Germany
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  • Hofheim, Germany
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  • Holzminden, Germany
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  • Homburg/Saar, Germany
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  • Huckelhoven, Germany
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  • Ilsede, Germany
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  • Ingolstadt, Germany
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  • Isny, Germany
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  • Itzehoe, Germany
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  • Jena, Germany
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  • Kahla, Germany
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  • Kalkar, Germany
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  • Karlsbad, Germany
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  • Karlsruhe, Germany
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  • Kassel, Germany
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  • Kaufbeuren, Germany
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  • Kempten, Germany
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  • Kerpen, Germany
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  • Kiel, Germany
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  • Koblenz, Germany
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  • Koln, Germany
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  • Konigs Wusterhausen, Germany
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  • Konstanz, Germany
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  • Korntal-Munchingen, Germany
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  • Krefeld, Germany
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  • Kreuztal, Germany
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  • Krumbach, Germany
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  • Kunzelsau, Germany
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  • Kusel, Germany
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  • Laatzen, Germany
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  • Lahnstein, Germany
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  • Landau, Germany
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  • Landshut, Germany
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  • Langen, Germany
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  • Langenhagen, Germany
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  • Lauf, Germany
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  • Lehrte, Germany
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  • Leichlingen, Germany
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  • Leipzig, Germany
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  • Leisnig, Germany
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  • Leonberg, Germany
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  • Leverkusen, Germany
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  • Lich, Germany
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  • Limburg, Germany
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  • Lingen, Germany
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  • Lobau, Germany
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  • Lohsa OT Weisskollm, Germany
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  • Lubeck, Germany
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  • Ludwigsfelde, Germany
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  • Ludwigshafen, Germany
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  • Luneburg, Germany
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  • Lunen, Germany
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  • Magdeburg, Germany
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  • Mannheim, Germany
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  • Marburg, Germany
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  • Marienheide, Germany
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  • Markranstadt, Germany
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  • Marktredwitz, Germany
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  • Marl, Germany
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  • Mayen, Germany
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  • Meiningen, Germany
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  • Meissen, Germany
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  • Memmingen, Germany
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  • Mendig, Germany
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  • Mettingen, Germany
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  • Metzingen, Germany
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  • Minden, Germany
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  • Mittweida, Germany
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  • Moers, Germany
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  • Monchengladbach, Germany
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  • Muhldorf, Germany
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  • Muhlhausen, Germany
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  • Muhlheim, Germany
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  • Mulheim a. d. Ruhr, Germany
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  • Munchen, Germany
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  • Munster, Germany
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  • Mutlangen, Germany
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  • Nauen, Germany
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  • Naunhof, Germany
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  • Neckarsulm, Germany
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  • Netphen, Germany
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  • Neubrandenburg, Germany
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  • Neuhaus am Rennweg, Germany
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  • Neumarkt, Germany
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  • Neumunster, Germany
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  • Neuruppin, Germany
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  • Neustadt, Germany
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  • Neustadt an der Weinstrasse, Germany
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  • Nienburg, Germany
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  • Nordhausen, Germany
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  • Nordhorn, Germany
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  • Numbrecht, Germany
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  • Nurnberg, Germany
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  • Nurtingen, Germany
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  • Oberhausen, Germany
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  • Oberstdorf, Germany
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  • Ochsenfurt, Germany
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  • Offenbach, Germany
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  • Offenburg, Germany
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  • Oranienburg, Germany
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  • Osnabruck, Germany
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  • Paderborn, Germany
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  • Parchim, Germany
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  • Passau, Germany
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  • Peine, Germany
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  • Penzberg, Germany
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  • Pfinztal, Germany
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  • Pforzheim, Germany
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  • Pfullingen, Germany
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  • Pinneberg, Germany
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  • Pirmasens, Germany
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  • Plauen-Kauschwitz, Germany
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  • Pocking, Germany
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  • Potsdam, Germany
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  • Quickborn, Germany
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  • Rahden, Germany
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  • Rangsdorf, Germany
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  • Ravensburg, Germany
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  • Recklinghausen, Germany
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  • Regensburg, Germany
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  • Reinbek, Germany
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  • Remchingen, Germany
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  • Remscheid, Germany
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  • Rendsburg, Germany
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  • Reutlingen, Germany
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  • Rheine, Germany
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  • Rheinfelden, Germany
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  • Riebnitz-Damgarten, Germany
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  • Riesa, Germany
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  • Rodewisch, Germany
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  • Rodgau, Germany
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  • Rosenheim, Germany
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  • Rosrath, Germany
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  • Rotenburg, Germany
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  • Rottenburg, Germany
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  • Rottweil, Germany
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  • Saarbrucken, Germany
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  • Saarlouis, Germany
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  • Salzgitter, Germany
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  • Salzwedel, Germany
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  • Sandhausen, Germany
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  • Sayda, Germany
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  • Schalksmuhle, Germany
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  • Scheibenberg, Germany
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  • Schkeuditz, Germany
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  • Schleswig, Germany
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  • Schonaich, Germany
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  • Schonebeck, Germany
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  • Schorndorf, Germany
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  • Schwabach, Germany
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  • Schwabisch Hall, Germany
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  • Schwandorf, Germany
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  • Schweinfurt, Germany
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  • Schwerin, Germany
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  • Schwerte, Germany
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  • Schwetzingen, Germany
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  • Sebnitz, Germany
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  • Senden, Germany
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  • Siegen, Germany
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  • Simmern, Germany
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  • Singen (Hohentwiel), Germany
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  • Sogel, Germany
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  • Solingen, Germany
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  • Sommerda, Germany
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  • Spremberg, Germany
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  • Sprockhovel, Germany
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  • St. Wendel, Germany
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  • Starnberg, Germany
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  • Stendal, Germany
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  • Stockelsdorf, Germany
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  • Stralsund, Germany
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  • Stuhr, Germany
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  • Stuttgart, Germany
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  • Sulzbach-Rosenberg, Germany
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  • Teltow, Germany
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  • Tettnang, Germany
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  • Torgau, Germany
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  • Tornesch, Germany
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  • Tubingen, Germany
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  • Uelzen, Germany
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  • Uetze, Germany
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  • Ulm, Germany
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  • Vechta, Germany
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  • Vechta-Langforden, Germany
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  • Veitshochheim, Germany
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  • Viersen, Germany
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  • Villingen-Schwenningen, Germany
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  • Vilsbiburg, Germany
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  • Vlotho, Germany
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  • Vohringen, Germany
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  • Volklingen, Germany
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  • Waldmunchen, Germany
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  • Walsrode, Germany
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  • Wangen, Germany
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  • Warburg, Germany
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  • Warendorf, Germany
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  • Warin, Germany
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  • Wasserburg, Germany
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  • Weiden in der Oberpfalz, Germany
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  • Weingarten, Germany
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  • Wermelskirchen, Germany
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  • Werneck, Germany
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  • Wertheim, Germany
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  • Wetzlar, Germany
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  • Wiesbaden, Germany
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  • Wilster, Germany
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  • Wismar, Germany
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  • Witten, Germany
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  • Witterda, Germany
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  • Wolfen, Germany
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  • Wolfsburg, Germany
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  • Worms, Germany
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  • Wuppertal, Germany
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  • Wurselen, Germany
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  • Wurzburg, Germany
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  • Zittau, Germany
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  • Zossen, Germany
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  • Zwickau, Germany
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  • Zwiesel, Germany
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  • Zwonitz, Germany
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All patients; treated with Anastrozole as per SPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	12 months
Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.	12 months
Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.	12 months
Identification of factors influencing and correlating to treatment-emergent arthralgias	12 months
Assessment of safety and tolerability of anastrozole.	12 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: H Brasch, AstraZeneca, Germany

Publications and helpful links

General Publications

• Hadji P, Jackisch C, Bolten W, Blettner M, Hindenburg HJ, Klein P, Konig K, Kreienberg R, Rief W, Wallwiener D, Zaun S, Harbeck N. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy. Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: November 9, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Primary early MCa; Arimidex
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: NIS-ODE-ARI-2008/1