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
CAROLEEN
1 other identifier
observational
3,250
2 countries
283
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Longer than P75 for all trials
283 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedStudy Start
First participant enrolled
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
June 1, 2026
May 1, 2026
5.4 years
February 4, 2025
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence
iDFS using STEEP (Standardized Definitions for Efficacy Endpoints in Adjuvant Breast Cancer Trials) criteria, as assessed by the investigator. iDFS is defined as the time from study start to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
36 months
Secondary Outcomes (28)
Number of participants per Baseline parameters
baseline
Reasons for treatment decision by treating physician
baseline
Patients' individual perception of risk of recurrence and treatment decision
baseline
Invasive disease-free survival (iDFS) (ribociclib cohort)
12 and 24 months
Invasive breast cancer-free survival (iBCFS) (ribociclib cohort)
12, 24 and 36 months
- +23 more secondary outcomes
Study Arms (3)
ribociclib
ribociclib + AI ± LHRH
abemaciclib
abemaciclib + ET ± LHRH
ET mono
ET mono ± LHRH
Interventions
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 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.
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
Adult female and male patients with an indication for adjuvant treatment with ribociclib + AI ± LHRH (or abemaciclib + ET ± LHRH for the abemaciclib cohort) in HR+/HER2- eBC at high risk of recurrence as described in the current effective summary of product characteristics enrolled from specialized centers, hospitals and outpatient centers.
You may qualify if:
- Histological diagnosis of HR+/HER2- early breast cancer with curative intent
- 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
You may not qualify if:
- \- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (283)
Novartis Investigative Site
Wiener Neustadt, Lower Austria, 2700, Austria
Novartis Investigative Site
Innsbruck, Tyrol, 6020, Austria
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Linz, Upper Austria, 4010, Austria
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Graz, 8036, Austria
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Klagenfurt, 9020, Austria
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Leoben, A 8700, Austria
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Schwaz, 6130, Austria
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Steyr, 4400, Austria
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Vienna, 1090, Austria
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Vienna, 1140, Austria
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Vienna, 1160, Austria
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Vienna, A-1130, Austria
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Baden-Baden, Baden-Wurttemberg, 76532, Germany
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Filderstadt, Baden-Wurttemberg, 70794, Germany
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Freudenstadt, Baden-Wurttemberg, 72250, Germany
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Heidelberg, Baden-Wurttemberg, 69115, Germany
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Heidenheim, Baden-Wurttemberg, 89522, Germany
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Konstanz, Baden-Wurttemberg, 78464, Germany
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Mannheim, Baden-Wurttemberg, 68161, Germany
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Mannheim, Baden-Wurttemberg, 68165, Germany
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Nürtingen, Baden-Wurttemberg, 72622, Germany
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Ostfildern, Baden-Wurttemberg, 73760, Germany
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Pforzheim, Baden-Wurttemberg, 75179, Germany
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Ravensburg, Baden-Wurttemberg, 88212, Germany
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Reutlingen, Baden-Wurttemberg, 72764, Germany
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Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
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Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany
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Winnenden, Baden-Wurttemberg, 71364, Germany
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Altötting, Bavaria, 84503, Germany
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Ansbach, Bavaria, 91522, Germany
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Augsburg, Bavaria, 86157, Germany
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Bamberg, Bavaria, 96049, Germany
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Bayreuth, Bavaria, 95445, Germany
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Dillingen an der Donau, Bavaria, 89407, Germany
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Donauwörth, Bavaria, 86609, Germany
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Ebersberg, Bavaria, 85560, Germany
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Erlangen, Bavaria, 91054, Germany
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Fürth, Bavaria, 90766, Germany
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Herrsching am Ammersee, Bavaria, 82211, Germany
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Kempten (Allgäu), Bavaria, 87439, Germany
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Kronach, Bavaria, 96317, Germany
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Landsberg am Lech, Bavaria, 86899, Germany
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Munich, Bavaria, 80637, Germany
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Munich, Bavaria, 81241, Germany
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Munich, Bavaria, 81377, Germany
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Munich, Bavaria, 81925, Germany
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Neumarkt in der Oberpfalz, Bavaria, 92318, Germany
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Prien am Chiemsee, Bavaria, 83209, Germany
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Regensburg, Bavaria, 93053, Germany
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Rosenheim, Bavaria, 83022, Germany
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Traunstein, Bavaria, 83278, Germany
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Ulm, Bavaria, 89073, Germany
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Waldmuenchen, Bavaria, 93449, Germany
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Weiden in Der Oberpfalz, Bavaria, 92637, Germany
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Weilheim, Bavaria, 82362, Germany
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Würzburg, Bavaria, 97070, Germany
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Brandenburg an der Havel, Brandenburg, 14770, Germany
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Cottbus, Brandenburg, 03048, Germany
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Königs Wusterhausen, Brandenburg, 15711, Germany
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Hamburg, Free and Hanseatic City of Hamburg, 22291, Germany
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Hamburg, Free and Hanseatic City of Hamburg, 22457, Germany
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Bremen, Free Hanseatic City of Bremen, 28209, Germany
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Bremen, Free Hanseatic City of Bremen, 28239, Germany
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Bremerhaven, Free Hanseatic City of Bremen, 27576, Germany
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Bad Homburg, Hesse, 61352, Germany
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Bad Nauheim, Hesse, 61231, Germany
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Frankfurt am Main, Hesse, 60398, Germany
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Frankfurt am Main, Hesse, 60431, Germany
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Frankfurt am Main, Hesse, 65929, Germany
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Langen, Hesse, 63225, Germany
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Marburg, Hesse, 35037, Germany
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Marburg, Hesse, 35043, Germany
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Wiesbaden, Hesse, 65189, Germany
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Wiesbaden, Hesse, 65199, Germany
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Braunschweig, Lower Saxony, 38100, Germany
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Buchholz Nordheide, Lower Saxony, 21244, Germany
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Georgsmarienhütte, Lower Saxony, 49124, Germany
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Göttingen, Lower Saxony, 37073, Germany
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Hildesheim, Lower Saxony, 31134, Germany
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Ilsede, Lower Saxony, 31241, Germany
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Lingen, Lower Saxony, 49808, Germany
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Osnabrück, Lower Saxony, 49076, Germany
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Rotenburg (Wümme), Lower Saxony, 27356, Germany
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Twistringen, Lower Saxony, 27239, Germany
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Westerstede, Lower Saxony, 26655, Germany
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Winsen, Lower Saxony, 21423, Germany
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Wolfenbüttel, Lower Saxony, 38304, Germany
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Wunstorf, Lower Saxony, 31515, Germany
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Rostock, Mecklenburg-Vorpommern, 18057, Germany
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Aachen, North Rhine-Westphalia, 52066, Germany
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Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
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Bielefeld, North Rhine-Westphalia, 33604, Germany
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Bielefeld, North Rhine-Westphalia, 33615, Germany
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Bochum, North Rhine-Westphalia, 44791, Germany
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Bonn, North Rhine-Westphalia, 53113, Germany
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Bonn, North Rhine-Westphalia, 53177, Germany
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Cologne, North Rhine-Westphalia, 50679, Germany
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Cologne, North Rhine-Westphalia, 50937, Germany
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Dortmund, North Rhine-Westphalia, 44137, Germany
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Düsseldorf, North Rhine-Westphalia, 40217, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Düsseldorf, North Rhine-Westphalia, 40625, Germany
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Mönchengladbach, North Rhine-Westphalia, 41061, Germany
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Olpe, North Rhine-Westphalia, 57462, Germany
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Paderborn, North Rhine-Westphalia, 33098, Germany
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Remscheid, North Rhine-Westphalia, 42853, Germany
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Remscheid, North Rhine-Westphalia, 42859, Germany
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Schwerte, North Rhine-Westphalia, 58239, Germany
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Siegen, North Rhine-Westphalia, 57072, Germany
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Troisdorf, North Rhine-Westphalia, 53840, Germany
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Velbert, North Rhine-Westphalia, 42551, Germany
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Mayen, Rhineland-Palatinate, 56727, Germany
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Neustadt an der Weinstraße, Rhineland-Palatinate, 67434, Germany
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Speyer, Rhineland-Palatinate, 67346, Germany
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Lebach, Saarland, 66822, Germany
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Borna, Saxony, 04552, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04103, Germany
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Neustadt in Sachsen, Saxony, 01844, Germany
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Plauen, Saxony, 08525, Germany
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Radebeul, Saxony, 01445, Germany
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Rodewisch, Saxony, 08228, Germany
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Scheibenberg, Saxony, 09481, Germany
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Schkeuditz, Saxony, 04435, Germany
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Zittau, Saxony, 02763, Germany
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Halle, Saxony-Anhalt, 06110, Germany
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Halle, Saxony-Anhalt, 06120, Germany
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Hansestadt Salzwedel, Saxony-Anhalt, 29410, Germany
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Magdeburg, Saxony-Anhalt, 39108, Germany
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Magdeburg, Saxony-Anhalt, 39130, Germany
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Stendal, Saxony-Anhalt, 39576, Germany
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Flensburg, Schleswig-Holstein, 24939, Germany
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Lübeck, Schleswig-Holstein, 23563, Germany
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Rendsburg, Schleswig-Holstein, 24768, Germany
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Berlin, State of Berlin, 13156, Germany
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Jena, Thuringia, 07740, Germany
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Mühlhausen, Thuringia, 99974, Germany
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Nordhausen, Thuringia, 99734, Germany
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Saalfeld, Thuringia, 07318, Germany
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Aachen, 52074, Germany
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Amberg, 92224, Germany
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Apolda, 99510, Germany
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Arnsberg, 59759, Germany
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Augsburg, 86150, Germany
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Bad Friedrichshall, 74177, Germany
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Bad Kreuznach, 55543, Germany
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Bad Langensalza, 99947, Germany
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Bad Mergentheim, 97980, Germany
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Bad Reichenhall, 83435, Germany
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Bad Saarow, 15526, Germany
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Bad Soden, 65812, Germany
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Balingen, 72336, Germany
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Bautzen, 02625, Germany
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Bayreuth, 95445, Germany
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Berlin, 10367, Germany
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Berlin, 10715, Germany
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Berlin, 12552, Germany
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Berlin, 13589, Germany
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Berlin, 14169, Germany
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Berlin, 14195, Germany
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Biberach, 88400, Germany
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Bochum, 44787, Germany
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Bonn, 53105, Germany
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Bonn, 53113, Germany
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Bonn, 53123, Germany
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Bottrop, 46236, Germany
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Böblingen, 71032, Germany
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Brandenburg, 14770, Germany
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Bremen, 28205, Germany
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Bremerhaven, 27574, Germany
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Bruchsal, 76646, Germany
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Celle, 29223, Germany
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Chemnitz, 09113, Germany
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Chemnitz, 09117, Germany
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Coburg, 96450, Germany
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Cologne, 50935, Germany
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Dachau, 85221, Germany
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Dessau, 06847, Germany
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Dorfen, 84405, Germany
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Dresden, 01127, Germany
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Dresden, 01307, Germany
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Duisburg, 47053, Germany
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Düsseldorf, 40235, Germany
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Eggenfelden, 84307, Germany
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Ehingen, 89584, Germany
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Ehrenfriedersdorf, 09427, Germany
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Eisenach, 99817, Germany
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Erding, 85435, Germany
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Erfurt, 99084, Germany
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Erfurt, 99085, Germany
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Eschweiler, 52249, Germany
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Essen, 45136, Germany
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Essen, 45147, Germany
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Esslingen am Neckar, 73730, Germany
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Eutin, 23701, Germany
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Freiburg im Breisgau, 79110, Germany
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Friedrichshafen, 88045, Germany
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Friedrichshafen, 88048, Germany
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Fürstenwalde, 15517, Germany
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Gengenbach, 77723, Germany
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Gera, 07548, Germany
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Gerlingen, 70839, Germany
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Goslar, 38642, Germany
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Göttingen, 37075, Germany
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Greifswald, 17489, Germany
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Gummersbach, 51643, Germany
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Günzburg, 89312, Germany
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Hagen, 58095, Germany
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Haldensleben I, 39340, Germany
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Hamburg, 20259, Germany
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Hamburg, 20357, Germany
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Hamburg, 21073, Germany
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Hanover, 30159, Germany
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Hanover, 30177, Germany
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Hanover, 30625, Germany
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Heide, 25746, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Hennigsdorf, 16761, Germany
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Herdecke, 58313, Germany
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Homburg, 66421, Germany
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Itzehoe, 25524, Germany
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Jena, 07747, Germany
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Kaiserslautern, 67655, Germany
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Karlsruhe, 76133, Germany
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Karlsruhe, 76135, Germany
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Kiel, 24103, Germany
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Krefeld, 47805, Germany
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Kulmbach, 95326, Germany
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Leer, 26789, Germany
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Leipzig, 04277, Germany
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Loerrach, 79539, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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Marktredwitz, 95615, Germany
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Memmingen, 87700, Germany
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Moers, 47441, Germany
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Mutlangen, 73557, Germany
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Münster, 48145, Germany
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Münster, 48149, Germany
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Naunhof, 04683, Germany
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Neubrandenburg, 17036, Germany
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Neumünster, 24534, Germany
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Neuss, 41462, Germany
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Nuremberg, 90403, Germany
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Nuremberg, 90419, Germany
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Offenburg, 77654, Germany
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Oldenburg, 26121, Germany
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Passau, 94036, Germany
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Potsdam, 14482, Germany
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Regensburg, 93053, Germany
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Rheine, 48431, Germany
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Rüsselsheim am Main, 65428, Germany
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Saarlouis, 66740, Germany
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Schorndorf, 73614, Germany
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Schweinfurt, 97422, Germany
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Siegen, 57074, Germany
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Sigmaringen, 72488, Germany
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Singen, 78224, Germany
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Sinsheim, 74889, Germany
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Soest, 59494, Germany
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Stendal, 39576, Germany
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Stralsund, 18439, Germany
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Stuttgart, 70174, Germany
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Stuttgart, 70176, Germany
Novartis Investigative Site
Stuttgart, 70199, Germany
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Suhl, 98527, Germany
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Torgau, 04860, Germany
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Traunstein, 83278, Germany
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Trier, 54290, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Waldkirchen, 94065, Germany
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Waldsassen, 95652, Germany
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Walsrode, 29664, Germany
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Weinheim, 69469, Germany
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Werdau, 08412, Germany
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Wernigerode, 38855, Germany
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Wesel, 46485, Germany
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Wetzlar, 35578, Germany
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Witten, 58452, Germany
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Worms, 67550, Germany
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Würzburg, 97080, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 17, 2025
Study Start
February 20, 2025
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Last Updated
June 1, 2026
Record last verified: 2026-05