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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | treated with Anastrozole as per SPC |
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| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| H Brasch | AstraZeneca, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aachen | Germany | Germany | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24355487 | Derived | 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. |
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| 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 |
| Aalen |
| Germany |
| Germany |
| Research Site | Ahaus | Germany | Germany |
| Research Site | Albstadt | Germany | Germany |
| Research Site | Altötting | Germany | Germany |
| Research Site | Alzey | Germany | Germany |
| Research Site | Amberg | Germany | Germany |
| Research Site | Apolda | Germany | Germany |
| Research Site | Aschaffenburg | Germany | Germany |
| Research Site | Aschersleben | Germany | Germany |
| Research Site | Augsburg | Germany | Germany |
| Research Site | Aurich | Germany | Germany |
| Research Site | Babenhausen | Germany | Germany |
| Research Site | Bad Dürkheim | Germany | Germany |
| Research Site | Bad Herrenalb | Germany | Germany |
| Research Site | Bad Nauheim | Germany | Germany |
| Research Site | Bad Neuenahr-Ahrweiler | Germany | Germany |
| Research Site | Bad Oeynhausen | Germany | Germany |
| Research Site | Bad Oldesloe | Germany | Germany |
| Research Site | Bad Reichenhall | Germany | Germany |
| Research Site | Bad Saarow | Germany | Germany |
| Research Site | Bad Segeberg | Germany | Germany |
| Research Site | Bad Tölz | Germany | Germany |
| Research Site | Bad Urach | Germany | Germany |
| Research Site | Bad Wildbad | Germany | Germany |
| Research Site | Bad Wildungen | Germany | Germany |
| Research Site | Bad Windsheim | Germany | Germany |
| Research Site | Baden-Baden | Germany | Germany |
| Research Site | Bamberg | Germany | Germany |
| Research Site | Bautzen | Germany | Germany |
| Research Site | Bayreuth | Germany | Germany |
| Research Site | Berlin | Germany | Germany |
| Research Site | Bexbach | Germany | Germany |
| Research Site | Biberach | Germany | Germany |
| Research Site | Biedenkopf | Germany | Germany |
| Research Site | Bielefeld | Germany | Germany |
| Research Site | Bietigheim-Bissingen | Germany | Germany |
| Research Site | Blankenburg | Germany | Germany |
| Research Site | Blumberg in Baden | Germany | Germany |
| Research Site | Bocholt | Germany | Germany |
| Research Site | Bochum | Germany | Germany |
| Research Site | Bonn | Germany | Germany |
| Research Site | Borna | Germany | Germany |
| Research Site | Bottrop | Germany | Germany |
| Research Site | Böblingen | Germany | Germany |
| Research Site | Brackenheim | Germany | Germany |
| Research Site | Bramsche | Germany | Germany |
| Research Site | Brandenburg | Germany | Germany |
| Research Site | Braunschweig | Germany | Germany |
| Research Site | Bretten | Germany | Germany |
| Research Site | Bruchsal | Germany | Germany |
| Research Site | Brühl | Germany | Germany |
| Research Site | Burg | Germany | Germany |
| Research Site | Burghausen | Germany | Germany |
| Research Site | Bühl | Germany | Germany |
| Research Site | Bünde | Germany | Germany |
| Research Site | Celle | Germany | Germany |
| Research Site | Chemnitz | Germany | Germany |
| Research Site | Cloppenburg | Germany | Germany |
| Research Site | Coburg | Germany | Germany |
| Research Site | Coesfeld | Germany | Germany |
| Research Site | Cologne | Germany | Germany |
| Research Site | Dachau | Germany | Germany |
| Research Site | Damme | Germany | Germany |
| Research Site | Datteln | Germany | Germany |
| Research Site | Demmin | Germany | Germany |
| Research Site | Dessau | Germany | Germany |
| Research Site | Dießen | Germany | Germany |
| Research Site | Dillenburg | Germany | Germany |
| Research Site | Dillingen | Germany | Germany |
| Research Site | Dinkelsbühl | Germany | Germany |
| Research Site | Ditzingen | Germany | Germany |
| Research Site | Doberlug-Kirchhain | Germany | Germany |
| Research Site | Dornstadt | Germany | Germany |
| Research Site | Dorsten | Germany | Germany |
| Research Site | Dortmund | Germany | Germany |
| Research Site | Dreieich | Germany | Germany |
| Research Site | Dresden | Germany | Germany |
| Research Site | Duisburg | Germany | Germany |
| Research Site | Düren | Germany | Germany |
| Research Site | Düsseldorf | Germany | Germany |
| Research Site | Ebermannstadt | Germany | Germany |
| Research Site | Ebersbach | Germany | Germany |
| Research Site | Eggenfelden | Germany | Germany |
| Research Site | Eisenach | Germany | Germany |
| Research Site | Ellwangen | Germany | Germany |
| Research Site | Elmshorn | Germany | Germany |
| Research Site | Emmendingen | Germany | Germany |
| Research Site | Erding | Germany | Germany |
| Research Site | Erfurt | Germany | Germany |
| Research Site | Ergolding | Germany | Germany |
| Research Site | Erkelenz | Germany | Germany |
| Research Site | Eschweiler | Germany | Germany |
| Research Site | Esens | Germany | Germany |
| Research Site | Essen | Germany | Germany |
| Research Site | Ettlingen | Germany | Germany |
| Research Site | Euskirchen | Germany | Germany |
| Research Site | Eutin | Germany | Germany |
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| Research Site | Flensburg | Germany | Germany |
| Research Site | Frankenberg | Germany | Germany |
| Research Site | Frankenthal | Germany | Germany |
| Research Site | Frankfurt (Oder) | Germany | Germany |
| Research Site | Frechen | Germany | Germany |
| Research Site | Freiburg im Breisgau | Germany | Germany |
| Research Site | Freising | Germany | Germany |
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| Research Site | Freyung | Germany | Germany |
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| Research Site | Fürstenwalde | Germany | Germany |
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| Research Site | Garbsen | Germany | Germany |
| Research Site | Geesthacht | Germany | Germany |
| Research Site | Geilenkirchen | Germany | Germany |
| Research Site | Gelsenkirchen | Germany | Germany |
| Research Site | Georgsmarienhütte | Germany | Germany |
| Research Site | Gera | Germany | Germany |
| Research Site | Geretsried | Germany | Germany |
| Research Site | Gerlingen | Germany | Germany |
| Research Site | Gersthofen | Germany | Germany |
| Research Site | Giesen | Germany | Germany |
| Research Site | Gifhorn | Germany | Germany |
| Research Site | Gladbeck | Germany | Germany |
| Research Site | Goslar | Germany | Germany |
| Research Site | Göppingen | Germany | Germany |
| Research Site | Göttingen | Germany | Germany |
| Research Site | Gräfelfing | Germany | Germany |
| Research Site | Griesheim | Germany | Germany |
| Research Site | Gummersbach | Germany | Germany |
| Research Site | Günzburg | Germany | Germany |
| Research Site | Güstrow | Germany | Germany |
| Research Site | Haiger | Germany | Germany |
| Research Site | Halberstadt | Germany | Germany |
| Research Site | Halle | Germany | Germany |
| Research Site | Hamburg | Germany | Germany |
| Research Site | Hamelin | Germany | Germany |
| Research Site | Hamm | Germany | Germany |
| Research Site | Hanover | Germany | Germany |
| Research Site | Hansestadt Salzwedel | Germany | Germany |
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| Research Site | Heidelberg | Germany | Germany |
| Research Site | Heidenheim | Germany | Germany |
| Research Site | Heilbronn | Germany | Germany |
| Research Site | Heinsberg | Germany | Germany |
| Research Site | Hemmingen | Germany | Germany |
| Research Site | Henstedt-Ulzburg | Germany | Germany |
| Research Site | Heppenheim an der Bergstrasse | Germany | Germany |
| Research Site | Herborn | Germany | Germany |
| Research Site | Herbrechtingen | Germany | Germany |
| Research Site | Herdecke | Germany | Germany |
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| Research Site | Hermsdorf | Germany | Germany |
| Research Site | Herne | Germany | Germany |
| Research Site | Herzberg | Germany | Germany |
| Research Site | Herzberg am Harz | Germany | Germany |
| Research Site | Hessisch Oldendorf | Germany | Germany |
| Research Site | Hilchenbach | Germany | Germany |
| Research Site | Hildesheim | Germany | Germany |
| Research Site | Hillesheim | Germany | Germany |
| Research Site | Hochstadt | Germany | Germany |
| Research Site | Hof | Germany | Germany |
| Research Site | Hofheim | Germany | Germany |
| Research Site | Holzminden | Germany | Germany |
| Research Site | Homburg/Saar | Germany | Germany |
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| Research Site | Kalkar | Germany | Germany |
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| Research Site | Karlsruhe | Germany | Germany |
| Research Site | Kassel | Germany | Germany |
| Research Site | Kaufbeuren | Germany | Germany |
| Research Site | Kempten | Germany | Germany |
| Research Site | Kerpen | Germany | Germany |
| Research Site | Kiel | Germany | Germany |
| Research Site | Koblenz | Germany | Germany |
| Research Site | Konstanz | Germany | Germany |
| Research Site | Korntal | Germany | Germany |
| Research Site | Königs Wusterhausen | Germany | Germany |
| Research Site | Krefeld | Germany | Germany |
| Research Site | Kreuzberg | Germany | Germany |
| Research Site | Kreuztal | Germany | Germany |
| Research Site | Krumbach | Germany | Germany |
| Research Site | Kusel | Germany | Germany |
| Research Site | Künzelsau | Germany | Germany |
| Research Site | Laatzen | Germany | Germany |
| Research Site | Lahnstein | Germany | Germany |
| Research Site | Landau | Germany | Germany |
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| Research Site | Langen | Germany | Germany |
| Research Site | Langenhagen | Germany | Germany |
| Research Site | Lauf | Germany | Germany |
| Research Site | Lehrte | Germany | Germany |
| Research Site | Leichlingen | Germany | Germany |
| Research Site | Leipzig | Germany | Germany |
| Research Site | Leisnig | Germany | Germany |
| Research Site | Leonberg | Germany | Germany |
| Research Site | Leverkusen | Germany | Germany |
| Research Site | Lich | Germany | Germany |
| Research Site | Limburg | Germany | Germany |
| Research Site | Lingen | Germany | Germany |
| Research Site | Lohsa OT Weisskollm | Germany | Germany |
| Research Site | Löbau | Germany | Germany |
| Research Site | Ludwigsfelde | Germany | Germany |
| Research Site | Ludwigshafen | Germany | Germany |
| Research Site | Lübeck | Germany | Germany |
| Research Site | Lüneburg | Germany | Germany |
| Research Site | Lünen | Germany | Germany |
| Research Site | Magdeburg | Germany | Germany |
| Research Site | Mannheim | Germany | Germany |
| Research Site | Marburg | Germany | Germany |
| Research Site | Marienheide | Germany | Germany |
| Research Site | Markranstädt | Germany | Germany |
| Research Site | Marktredwitz | Germany | Germany |
| Research Site | Marl | Germany | Germany |
| Research Site | Mayen | Germany | Germany |
| Research Site | Meiningen | Germany | Germany |
| Research Site | Meissen | Germany | Germany |
| Research Site | Memmingen | Germany | Germany |
| Research Site | Mendig | Germany | Germany |
| Research Site | Mettingen | Germany | Germany |
| Research Site | Metzingen | Germany | Germany |
| Research Site | Minden | Germany | Germany |
| Research Site | Mittweida | Germany | Germany |
| Research Site | Moers | Germany | Germany |
| Research Site | Mönchengladbach | Germany | Germany |
| Research Site | Mulheim A. D. Ruhr | Germany | Germany |
| Research Site | Mutlangen | Germany | Germany |
| Research Site | Mühldorf | Germany | Germany |
| Research Site | Mühlhausen | Germany | Germany |
| Research Site | Mühlheim | Germany | Germany |
| Research Site | München | Germany | Germany |
| Research Site | Münster | Germany | Germany |
| Research Site | Nauen | Germany | Germany |
| Research Site | Naunhof | Germany | Germany |
| Research Site | Neckarsulm | Germany | Germany |
| Research Site | Netphen | Germany | Germany |
| Research Site | Neubrandenburg | Germany | Germany |
| Research Site | Neuhaus am Rennweg | Germany | Germany |
| Research Site | Neumarkt | Germany | Germany |
| Research Site | Neumünster | Germany | Germany |
| Research Site | Neuruppin | Germany | Germany |
| Research Site | Neustadt | Germany | Germany |
| Research Site | Neustadt an der Weinstraße | Germany | Germany |
| Research Site | Nienburg | Germany | Germany |
| Research Site | Nordhausen | Germany | Germany |
| Research Site | Nordhorn | Germany | Germany |
| Research Site | Nuremberg | Germany | Germany |
| Research Site | Nümbrecht | Germany | Germany |
| Research Site | Nürtingen | Germany | Germany |
| Research Site | Oberhausen | Germany | Germany |
| Research Site | Oberstdorf | Germany | Germany |
| Research Site | Ochsenfurt | Germany | Germany |
| Research Site | Offenbach | Germany | Germany |
| Research Site | Offenburg | Germany | Germany |
| Research Site | Oranienburg | Germany | Germany |
| Research Site | Osnabrück | Germany | Germany |
| Research Site | Paderborn | Germany | Germany |
| Research Site | Parchim | Germany | Germany |
| Research Site | Passau | Germany | Germany |
| Research Site | Peine | Germany | Germany |
| Research Site | Penzberg | Germany | Germany |
| Research Site | Pfinztal | Germany | Germany |
| Research Site | Pforzheim | Germany | Germany |
| Research Site | Pfullingen | Germany | Germany |
| Research Site | Pinneberg | Germany | Germany |
| Research Site | Pirmasens | Germany | Germany |
| Research Site | Plauen-Kauschwitz | Germany | Germany |
| Research Site | Pocking | Germany | Germany |
| Research Site | Potsdam | Germany | Germany |
| Research Site | Quickborn | Germany | Germany |
| Research Site | Rahden | Germany | Germany |
| Research Site | Rangsdorf | Germany | Germany |
| Research Site | Ravensburg | Germany | Germany |
| Research Site | Recklinghausen | Germany | Germany |
| Research Site | Regensburg | Germany | Germany |
| Research Site | Reinbek | Germany | Germany |
| Research Site | Remchingen | Germany | Germany |
| Research Site | Remscheid | Germany | Germany |
| Research Site | Rendsburg | Germany | Germany |
| Research Site | Reutlingen | Germany | Germany |
| Research Site | Rheine | Germany | Germany |
| Research Site | Rheinfelden | Germany | Germany |
| Research Site | Riebnitz-Damgarten | Germany | Germany |
| Research Site | Riesa | Germany | Germany |
| Research Site | Rodewisch | Germany | Germany |
| Research Site | Rodgau | Germany | Germany |
| Research Site | Rosenheim | Germany | Germany |
| Research Site | Rotenburg (Wümme) | Germany | Germany |
| Research Site | Rottenburg | Germany | Germany |
| Research Site | Rottweil | Germany | Germany |
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| Research Site | Saarbrücken | Germany | Germany |
| Research Site | Saarlouis | Germany | Germany |
| Research Site | Saint Wendel | Germany | Germany |
| Research Site | Salzgitter | Germany | Germany |
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| Research Site | Sayda | Germany | Germany |
| Research Site | Schalksmühle | Germany | Germany |
| Research Site | Scheibenberg | Germany | Germany |
| Research Site | Schkeuditz | Germany | Germany |
| Research Site | Schleswig | Germany | Germany |
| Research Site | Schorndorf | Germany | Germany |
| Research Site | Schönaich | Germany | Germany |
| Research Site | Schönebeck | Germany | Germany |
| Research Site | Schwabach | Germany | Germany |
| Research Site | Schwandorf in Bayern | Germany | Germany |
| Research Site | Schwäbisch Hall | Germany | Germany |
| Research Site | Schweinfurt | Germany | Germany |
| Research Site | Schwerin | Germany | Germany |
| Research Site | Schwerte | Germany | Germany |
| Research Site | Schwetzingen | Germany | Germany |
| Research Site | Sebnitz | Germany | Germany |
| Research Site | Senden | Germany | Germany |
| Research Site | Siegen | Germany | Germany |
| Research Site | Simmern | Germany | Germany |
| Research Site | Singen (Hohentwiel) | Germany | Germany |
| Research Site | Solingen | Germany | Germany |
| Research Site | Sögel | Germany | Germany |
| Research Site | Sömmerda | Germany | Germany |
| Research Site | Spremberg | Germany | Germany |
| Research Site | Sprockhövel | Germany | Germany |
| Research Site | Starnberg | Germany | Germany |
| Research Site | Steglitz | Germany | Germany |
| Research Site | Stendal | Germany | Germany |
| Research Site | Stockelsdorf | Germany | Germany |
| Research Site | Stralsund | Germany | Germany |
| Research Site | Stuhr | Germany | Germany |
| Research Site | Stuttgart | Germany | Germany |
| Research Site | Sulzbach-Rosenberg | Germany | Germany |
| Research Site | Teltow | Germany | Germany |
| Research Site | Tettnang | Germany | Germany |
| Research Site | Torgau | Germany | Germany |
| Research Site | Tornesch | Germany | Germany |
| Research Site | Tübingen | Germany | Germany |
| Research Site | Uelzen | Germany | Germany |
| Research Site | Uetze | Germany | Germany |
| Research Site | Ulm | Germany | Germany |
| Research Site | Vechta | Germany | Germany |
| Research Site | Vechta-Langforden | Germany | Germany |
| Research Site | Veitshöchheim | Germany | Germany |
| Research Site | Viersen | Germany | Germany |
| Research Site | Villingen-Schwenningen | Germany | Germany |
| Research Site | Vilsbiburg | Germany | Germany |
| Research Site | Vlotho | Germany | Germany |
| Research Site | Vöhringen | Germany | Germany |
| Research Site | Völklingen | Germany | Germany |
| Research Site | Waldmünchen | Germany | Germany |
| Research Site | Walsrode | Germany | Germany |
| Research Site | Wangen | Germany | Germany |
| Research Site | Warburg | Germany | Germany |
| Research Site | Warendorf | Germany | Germany |
| Research Site | Warin | Germany | Germany |
| Research Site | Wasserburg | Germany | Germany |
| Research Site | Weiden in Der Oberpfalz | Germany | Germany |
| Research Site | Weingarten | Germany | Germany |
| Research Site | Wermelskirchen | Germany | Germany |
| Research Site | Werneck | Germany | Germany |
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| Research Site | Worms | Germany | Germany |
| Research Site | Wuppertal | Germany | Germany |
| Research Site | Würselen | Germany | Germany |
| Research Site | Würzburg | Germany | Germany |
| Research Site | Zittau | Germany | Germany |
| Research Site | Zossen | Germany | Germany |
| Research Site | Zwickau | Germany | Germany |
| Research Site | Zwiesel | Germany | Germany |
| Research Site | Zwönitz | Germany | Germany |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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