Study Description
This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life. This non-interventional study aims to provide information on real-world effectiveness, safety and tolerability, management of adverse events, QoL and patient compliance of patients with HR+/HER2- early breast cancer at high risk of recurrence treated with ribociclib in combination with an non-steroidal aromatase inhibitor (NSAI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the German summary of product characteristics.
In order to put the results of patients treated with ribociclib into perspective, socio-economic data, data on QoL and patient compliance will also be collected from patients treated with abemaciclib + endocrine therapy (ET) ± LHRH as described in the respective local summary of product characteristics.
To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + NSAI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + NSAI ± LHRH, abemaciclib + ET ± LHRH, and additionally from patients treated with ET monotherapy ± LHRH and analyzed cross-sectionally.
The study is planned to be rolled out into a broad set of German and optionally Austrian and Swiss breast centers and gynecological practices to describe clinical routine in a representative subset of the local healthcare eco-system. It will gather insights into the potential benefits and risks associated with ribociclib + NSAI ± LHRH in the adjuvant treatment of HR+/HER2- eBC patients at high risk of recurrence. This knowledge will inform about clinical decision-making and contribute to improved patient outcomes in routine practice.
Interventions
abemaciclib + ET ± LHRH
ET mono ± LHRH
ribociclib + NSAI ± LHRH
Eligibility Criteria
Inclusion Criteria:
* Histological diagnosis of HR+/HER2- early breast cancer with curative intent
* Patients must have an indication for a treatment with ribociclib + NSAI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + NSAI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/"Fachinformation" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting
* Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either
* ribociclib + NSAI ± LHRH, or
* ET mono ± LHRH, or
* abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.
Baseline = for ribociclib + NSAI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: 4 weeks after therapy start or 4 weeks after last non-endocrine based therapy, whichever is last.
* ≥18 years of age
* Written informed consent
Exclusion Criteria:
* Patient is currently under active treatment in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib
* For ribociclib + NSAI ± LHRH cohort: ET pre-treatment is longer than 12 months, according to the current SmPC/"Fachinformation" of ribociclib; for abemaciclib + ET ± LHRH cohort: ET pre-treatment is longer than 12 weeks, according to the current SmPC/"Fachinformation" of abemaciclib
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Ravensburg,Baden-Wurttemberg,88212,Germany
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Winnenden,Baden-Wurttemberg,71364,Germany
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Donauwörth,Bavaria,86609,Germany
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Würzburg,Bavaria,97070,Germany
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Bad Nauheim,Hesse,61231,Germany
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Langen,Hesse,63225,Germany
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Marburg,Hesse,35037,Germany
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Twistringen,Lower Saxony,27239,Germany
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Westerstede,Lower Saxony,26655,Germany
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Wolfenbüttel,Lower Saxony,38304,Germany
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Wunstorf,Lower Saxony,31515,Germany
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Troisdorf,North Rhine-Westphalia,53840,Germany
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Salzwedel,Saxony,29410,Germany
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Scheibenberg,Saxony,09481,Germany
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Zittau,Saxony,02763,Germany
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Augsburg,86150,Germany
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Bad Langensalza,99947,Germany
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Balingen,72336,Germany
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Berlin,10715,Germany
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Berlin,State of Berlin,13156,Germany
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Biberach,88400,Germany
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Bonn,53123,Germany
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Brandenburg,Brandenburg,14770,Germany
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Bremen,City state Bremen,28209,Germany
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Dresden,01127,Germany
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Dresden,Saxony,01307,Germany
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Ehrenfriedersdorf,09427,Germany
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Erfurt,99085,Germany
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Essen,45136,Germany
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Essen,45147,Germany
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Fürstenwalde,15517,Germany
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Hamburg,21073,Germany
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Hamburg,City state of Hamburg,22457,Germany
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Krefeld,47805,Germany
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Marktredwitz,95615,Germany
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Neustadt in Sachsen,01844,Germany
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Oldenburg,26121,Germany
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Plauen Kauschwitz,08525,Germany
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Rotenburg (Wümme),27356,Germany
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Werdau,08412,Germany
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Filderstadt,Baden-Wurttemberg,70794,Germany
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Freudenstadt,Baden-Wurttemberg,72250,Germany
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Heidenheim,Baden-Wurttemberg,89522,Germany
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Pforzheim,Baden-Wurttemberg,75179,Germany
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Schwaebisch,Baden-Wurttemberg,74523,Germany
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Bayreuth,Bavaria,95445,Germany
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Fürth,Bavaria,90766,Germany
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Traunstein,Bavaria,83278,Germany
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Georgsmarienhütte,Lower Saxony,49124,Germany
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Hildesheim,Lower Saxony,31134,Germany
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Velbert,North Rhine-Westphalia,42551,Germany
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Halle,Saxony-Anhalt,06110,Germany
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Bonn,North Rhine-Westphalia,53113,Germany
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Bremen,City state Bremen,28239,Germany
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Celle,29223,Germany
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Chemnitz,09117,Germany
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Düsseldorf,North Rhine-Westphalia,40217,Germany
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Düsseldorf,40235,Germany
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Goslar,38642,Germany
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Cologne,50935,Germany
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Kulmbach,95326,Germany
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Loerrach,79539,Germany
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Neubrandenburg,17036,Germany
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Neuss,41462,Germany
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Nordhausen,99734,Germany
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Rostock,18507,Germany
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Schweinfurt,97422,Germany
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Singen,78224,Germany
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Stralsund,18439,Germany
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Ulm,89703,Germany
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Waldkirchen,94065,Germany
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Würzburg,97080,Germany
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Munich,Bavaria,81241,Germany
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Ilsede,Lower Saxony,31241,Germany
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Saalfeld,07318,Germany
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Cottbus,Brandenburg,03048,Germany
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Bremerhaven,City state Bremen,27576,Germany
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Wiesbaden,Hesse,65189,Germany
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Rostock,Mecklenburg-Vorpommern,18057,Germany
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Braunschweig,Lower Saxony,38100,Germany
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Osnabrück,Lower Saxony,49076,Germany
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Bielefeld,North Rhine-Westphalia,33604,Germany
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Lebach,Saarland,66822,Germany
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Stendal,Saxony-Anhalt,39576,Germany
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Magdeburg,Saxony-Anhalt,39108,Germany
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Magdeburg,Saxony-Anhalt,39130,Germany
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Lübeck,Schleswig-Holstein,23563,Germany
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Aachen,52074,Germany
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Bamberg,96049,Germany
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Bautzen,02625,Germany
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Bremerhaven,27574,Germany
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Chemnitz,09113,Germany
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Eggenfelden,84307,Germany
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Gera,07548,Germany
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Gerlingen,70839,Germany
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Günzburg,89312,Germany
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Gummersbach,51643,Germany
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Hanover,30177,Germany
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Jena,Thuringia,07740,Germany
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Kempten,87439,Germany
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Naunhof,04683,Germany
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Passau,94036,Germany
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Schorndorf,73614,Germany
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Sigmaringen,72488,Germany
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Torgau,04860,Germany
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Tübingen,72076,Germany
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Weiden,92637,Germany
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Mannheim,Baden-Wurttemberg,68161,Germany
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Ebersberg,Bavaria,85560,Germany
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Landsberg am Lech,Bavaria,86899,Germany
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Rosenheim,Bavaria,83022,Germany
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Waldmuenchen,Bavaria,93449,Germany
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Marburg,Hesse,35043,Germany
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Amberg,92224,Germany
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Berlin,10967,Germany
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Berlin,14169,Germany
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Bochum,44787,Germany
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Bruchsal,76646,Germany
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Dessau,06847,Germany
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Dillingen A D Donau,89407,Germany
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Hamburg,20259,Germany
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Heilbronn,74078,Germany
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Mutlangen,73557,Germany
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Nuremberg,90419,Germany
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Prien A Chiemsee,83209,Germany
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Suhl,98527,Germany
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Trier,54290,Germany
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Ulm,89081,Germany
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Altötting,Bavaria,84503,Germany
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Ansbach,Bavaria,91522,Germany
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Kronach,Bavaria,96317,Germany
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Bad Homburg,Hesse,61352,Germany
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Siegen,North Rhine-Westphalia,57072,Germany
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Speyer,Rhineland-Palatinate,67346,Germany
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Halle,Saxony-Anhalt,06120,Germany
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Borna,Saxony,04552,Germany
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Düsseldorf,North Rhine-Westphalia,40225,Germany
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Hamburg,City state of Hamburg,22291,Germany
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Homburg,66421,Germany
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Stuttgart,70176,Germany
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Weinheim,69469,Germany
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Witten,58452,Germany
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Munich,Bavaria,80637,Germany
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Munich,Bavaria,81377,Germany
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Düsseldorf,North Rhine-Westphalia,40625,Germany
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Flensburg,Schleswig-Holstein,24939,Germany
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Mühlhausen,Thuringia,99974,Germany
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Bad Reichenhall,83435,Germany
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Hagen,58095,Germany
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Heide,25746,Germany
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Mönchengladbach,North Rhine-Westphalia,41061,Germany
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Münster,48149,Germany
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Konstanz,Baden-Wurttemberg,78464,Germany
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Schwerte,Germany,58239,Germany
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Radebeul,Saxony,01445,Germany
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Dorfen,84405,Germany
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Kiel,24103,Germany
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Nuremberg,90403,Germany
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Rüsselsheim am Main,65428,Germany
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Saarlouis,66740,Germany
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