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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
Sponsor: Novartis Pharmaceuticals
Summary
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.
Official title: 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 to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
3250
Start Date
2025-02-20
Completion Date
2030-06-30
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (287)
Novartis Investigative Site
Wiener Neustadt, Lower Austria, Austria
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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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Vienna, Austria
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Baden-Baden, Baden-Wurttemberg, Germany
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Filderstadt, Baden-Wurttemberg, Germany
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Freudenstadt, Baden-Wurttemberg, Germany
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Heidelberg, 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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Schwäbisch Hall, Baden-Wurttemberg, Germany
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Villingen-Schwenningen, 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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Bamberg, Bavaria, Germany
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Bayreuth, Bavaria, Germany
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Dillingen an der Donau, 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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Neumarkt in der Oberpfalz, Bavaria, Germany
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Prien am Chiemsee, 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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Ulm, Bavaria, Germany
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Waldmuenchen, Bavaria, Germany
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Weiden in Der Oberpfalz, Bavaria, Germany
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Weilheim, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Brandenburg an der Havel, Brandenburg, Germany
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Cottbus, Brandenburg, Germany
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Königs Wusterhausen, Brandenburg, Germany
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Hamburg, Free and Hanseatic City of Hamburg, Germany
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Hamburg, Free and Hanseatic City of Hamburg, Germany
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Bremen, Free Hanseatic City of Bremen, Germany
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Bremen, Free Hanseatic City of Bremen, Germany
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Bremerhaven, Free Hanseatic City of Bremen, 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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Wiesbaden, Hesse, Germany
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Braunschweig, Lower Saxony, Germany
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Buchholz Nordheide, 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, Lower Saxony, Germany
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Osnabrück, Lower Saxony, Germany
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Rotenburg (Wümme), Lower Saxony, Germany
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Twistringen, Lower Saxony, Germany
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Westerstede, Lower Saxony, Germany
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Winsen, 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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Aachen, North Rhine-Westphalia, 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