A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence
NCT ID: NCT06830720
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3250 participants
OBSERVATIONAL
2025-02-20
2030-06-30
Brief Summary
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Detailed Description
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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 current effective local summary of product characteristics.
To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + AI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + AI ± 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 Austrian 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 + AI ± 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ribociclib
ribociclib + AI ± LHRH
ribociclib + AI ± LHRH
ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
abemaciclib
abemaciclib + ET ± LHRH
abemaciclib + ET ± LHRH
abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
ET mono
ET mono ± LHRH
ET mono ± LHRH
endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Interventions
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ribociclib + AI ± LHRH
ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
abemaciclib + ET ± LHRH
abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
ET mono ± LHRH
endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Eligibility Criteria
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Inclusion Criteria
* Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± 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 + AI ± 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 + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.
* ≥18 years of age
* Written informed consent
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Innsbruck, Tyrol, Austria
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Linz, Upper Austria, Austria
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Graz, , Austria
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Klagenfurt, , Austria
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Leoben, , Austria
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Schwaz, , Austria
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Steyr, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Filderstadt, Baden-Wurttemberg, Germany
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Freudenstadt, Baden-Wurttemberg, Germany
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Heidenheim, Baden-Wurttemberg, Germany
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Konstanz, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Nürtingen, Baden-Wurttemberg, Germany
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Ostfildern, Baden-Wurttemberg, Germany
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Pforzheim, Baden-Wurttemberg, Germany
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Ravensburg, Baden-Wurttemberg, Germany
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Reutlingen, Baden-Wurttemberg, Germany
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Schwaebisch, Baden-Wurttemberg, Germany
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Winnenden, Baden-Wurttemberg, Germany
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Altötting, Bavaria, Germany
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Ansbach, Bavaria, Germany
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Augsburg, Bavaria, Germany
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Bayreuth, Bavaria, Germany
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Donauwörth, Bavaria, Germany
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Ebersberg, Bavaria, Germany
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Erlangen, Bavaria, Germany
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Fürth, Bavaria, Germany
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Herrsching am Ammersee, Bavaria, Germany
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Kempten (Allgäu), Bavaria, Germany
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Kronach, Bavaria, Germany
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Landsberg am Lech, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Rosenheim, Bavaria, Germany
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Traunstein, Bavaria, Germany
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Waldmuenchen, Bavaria, Germany
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Weilheim, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Brandenburg, Brandenburg, Germany
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Cottbus, Brandenburg, Germany
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Königs Wusterhausen, Brandenburg, Germany
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Bremen, City state Bremen, Germany
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Bremen, City state Bremen, Germany
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Bremerhaven, City state Bremen, Germany
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Schwerte, Germany, Germany
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Hamburg, Hamburg, Germany
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Hamburg, Hamburg, Germany
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Bad Homburg, Hesse, Germany
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Bad Nauheim, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Langen, Hesse, Germany
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Marburg, Hesse, Germany
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Marburg, Hesse, Germany
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Wiesbaden, Hesse, Germany
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Braunschweig, Lower Saxony, Germany
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Georgsmarienhütte, Lower Saxony, Germany
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Göttingen, Lower Saxony, Germany
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Hildesheim, Lower Saxony, Germany
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Ilsede, Lower Saxony, Germany
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Lingen Ems, Lower Saxony, Germany
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Osnabrück, Lower Saxony, Germany
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Twistringen, Lower Saxony, Germany
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Westerstede, Lower Saxony, Germany
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Wolfenbüttel, Lower Saxony, Germany
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Wunstorf, Lower Saxony, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Bergisch Gladbach, North Rhine-Westphalia, Germany
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Bielefeld, North Rhine-Westphalia, Germany
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Bielefeld, North Rhine-Westphalia, Germany
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Bochum, North Rhine-Westphalia, Germany
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Bonn, North Rhine-Westphalia, Germany
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Bonn, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Mönchengladbach, North Rhine-Westphalia, Germany
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Olpe, North Rhine-Westphalia, Germany
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Paderborn, North Rhine-Westphalia, Germany
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Remscheid, North Rhine-Westphalia, Germany
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Siegen, North Rhine-Westphalia, Germany
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Troisdorf, North Rhine-Westphalia, Germany
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Velbert, North Rhine-Westphalia, Germany
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Remscheid Innen, Northrhine Westfalia, Germany
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Speyer, Rhineland-Palatinate, Germany
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Lebach, Saarland, Germany
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Borna, Saxony, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Radebeul, Saxony, Germany
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Rodewisch, Saxony, Germany
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Salzwedel, Saxony, Germany
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Scheibenberg, Saxony, Germany
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Schkeuditz, Saxony, Germany
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Zittau, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Halle, Saxony-Anhalt, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Stendal, Saxony-Anhalt, Germany
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Flensburg, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Jena, Thuringia, Germany
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Mühlhausen, Thuringia, Germany
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Aachen, , Germany
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Amberg, , Germany
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Apolda, , Germany
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Augsburg, , Germany
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Bad Friedrichshall, , Germany
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Bad Langensalza, , Germany
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Bad Mergentheim, , Germany
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Bad Reichenhall, , Germany
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Bad Soden, , Germany
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Baden-Baden, , Germany
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Balingen, , Germany
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Bamberg, , Germany
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Bautzen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Biberach, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Bonn, , Germany
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Bottrop, , Germany
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Böblingen, , Germany
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Brandenburg, , Germany
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Bremen, , Germany
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Bremerhaven, , Germany
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Bruchsal, , Germany
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Celle, , Germany
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Chemnitz, , Germany
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Chemnitz, , Germany
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Coburg, , Germany
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Cologne, , Germany
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Dachau, , Germany
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Dessau, , Germany
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Dillingen A D Donau, , Germany
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Dorfen, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Eggenfelden, , Germany
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Ehingen, , Germany
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Ehrenfriedersdorf, , Germany
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Erfurt, , Germany
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Erfurt, , Germany
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Eschweiler, , Germany
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Essen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Freiburg im Breisgau, , Germany
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Fürstenwalde, , Germany
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Gera, , Germany
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Gerlingen, , Germany
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Goslar, , Germany
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Göttingen, , Germany
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Gummersbach, , Germany
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Günzburg, , Germany
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Hagen, , Germany
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Haldensleben I, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heide, , Germany
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Heidelberg, , Germany
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Heilbronn, , Germany
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Hennigsdorf, , Germany
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Herdecke, , Germany
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Homburg, , Germany
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Jena, , Germany
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Kaiserslautern, , Germany
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Karlsruhe, , Germany
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Kiel, , Germany
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Krefeld, , Germany
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Kulmbach, , Germany
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Leipzig, , Germany
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Loerrach, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Marktredwitz, , Germany
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Memmingen, , Germany
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Moers, , Germany
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Mutlangen, , Germany
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Münster, , Germany
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Münster, , Germany
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Naunhof, , Germany
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Neubrandenburg, , Germany
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Neuss, , Germany
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Neustadt in Sachsen, , Germany
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Nordhausen, , Germany
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Nuremberg, , Germany
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Nuremberg, , Germany
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Offenburg, , Germany
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Oldenburg, , Germany
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Passau, , Germany
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Plauen Kauschwitz, , Germany
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Potsdam, , Germany
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Prien A Chiemsee, , Germany
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Regensburg, , Germany
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Rendsburg, , Germany
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Rheine, , Germany
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Rostock, , Germany
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Rotenburg (Wümme), , Germany
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Rüsselsheim am Main, , Germany
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Saalfeld, , Germany
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Saarlouis, , Germany
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Schorndorf, , Germany
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Schweinfurt, , Germany
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Siegen, , Germany
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Sigmaringen, , Germany
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Singen, , Germany
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Sinsheim, , Germany
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Soest, , Germany
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Stendal, , Germany
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Stralsund, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Suhl, , Germany
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Torgau, , Germany
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Traunstein, , Germany
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Trier, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Ulm, , Germany
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Villingen, , Germany
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Waldkirchen, , Germany
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Waldsassen, , Germany
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Walsrode, , Germany
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Weiden, , Germany
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Weinheim, , Germany
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Werdau, , Germany
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Wernigerode, , Germany
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Wesel, , Germany
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Wetzlar, , Germany
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Wiesbaden, , Germany
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Winse Luhe, , Germany
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Witten, , Germany
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Worms, , Germany
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Würzburg, , Germany
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CLEE011O1DE01
Identifier Type: -
Identifier Source: org_study_id