AzTrials
AzTrials

Breast NeoplasmsCAROLEENNCT06830720

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

An observational study of Breast Neoplasms, run by Novartis Pharmaceuticals at 287 sites in 2 countries.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Breast Neoplasms
What is being tested?
ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH and ET mono ± LHRH
How many people
3,250 participants
Where
287 sitesin 2 countries
Study dates
20 Feb 2025to 30 Jun 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.

Trial locations and contacts

287 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

287 sites in 2 countries

Germany275 sites, 273 recruiting

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52066

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    Aachen, 52074

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  • Novartis Investigative Site

    Altötting, Bavaria, 84503

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    Amberg, 92224

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  • Novartis Investigative Site

    Ansbach, Bavaria, 91522

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    Apolda, 99510

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    Arnsberg, 59759

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    Augsburg, Bavaria, 86157

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    Augsburg, 86150

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    Bad Friedrichshall, 74177

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    Bad Homburg, Hesse, 61352

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    Bad Kreuznach, 55543

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    Bad Langensalza, 99947

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    Bad Mergentheim, 97980

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    Bad Nauheim, Hesse, 61231

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    Bad Reichenhall, 83435

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    Bad Saarow, 15526

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    Bad Soden, 65812

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    Baden-Baden, Baden-Wurttemberg, 76532

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    Balingen, 72336

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    Bamberg, Bavaria, 96049

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    Bautzen, 02625

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    Bayreuth, Bavaria, 95445

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    Bayreuth, 95445

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    Bergisch Gladbach, North Rhine-Westphalia, 51465

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    Berlin, State of Berlin, 13156

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    Berlin, 10367

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    Berlin, 10715

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    Berlin, 12552

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    Berlin, 13589

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    Berlin, 14169

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    Berlin, 14195

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    Biberach, 88400

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    Bielefeld, North Rhine-Westphalia, 33604

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    Bielefeld, North Rhine-Westphalia, 33615

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    Böblingen, 71032

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    Bochum, North Rhine-Westphalia, 44791

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    Bochum, 44787

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    Bonn, North Rhine-Westphalia, 53113

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    Bonn, North Rhine-Westphalia, 53177

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    Bonn, 53105

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    Bonn, 53113

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    Bonn, 53123

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    Borna, Saxony, 04552

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    Bottrop, 46236

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    Brandenburg, 14770

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    Brandenburg an der Havel, Brandenburg, 14770

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    Braunschweig, Lower Saxony, 38100

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    Bremen, Free Hanseatic City of Bremen, 28209

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    Bremen, Free Hanseatic City of Bremen, 28239

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    Bremen, 28205

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    Bremerhaven, Free Hanseatic City of Bremen, 27576

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    Bremerhaven, 27574

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    Bruchsal, 76646

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    Buchholz Nordheide, Lower Saxony, 21244

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    Celle, 29223

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    Chemnitz, 09113

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    Chemnitz, 09117

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    Coburg, 96450

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    Cologne, North Rhine-Westphalia, 50679

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    Cologne, North Rhine-Westphalia, 50937

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    Cologne, 50935

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    Cottbus, Brandenburg, 03048

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    Dachau, 85221

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    Dessau, 06847

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    Dillingen an der Donau, Bavaria, 89407

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    Donauwörth, Bavaria, 86609

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    Dorfen, 84405

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    Dortmund, North Rhine-Westphalia, 44137

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    Dresden, Saxony, 01307

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    Dresden, 01127

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    Dresden, 01307

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    Duisburg, 47053

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    Düsseldorf, North Rhine-Westphalia, 40217

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    Düsseldorf, North Rhine-Westphalia, 40225

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    Düsseldorf, North Rhine-Westphalia, 40625

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    Düsseldorf, 40235

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    Ebersberg, Bavaria, 85560

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    Eggenfelden, 84307

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    Ehingen, 89584

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    Ehrenfriedersdorf, 09427

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    Eisenach, 99817

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    Erding, 85435

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    Erfurt, 99084

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    Erfurt, 99085

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    Erlangen, Bavaria, 91054

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    Eschweiler, 52249

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    Essen, 45136

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    Essen, 45147

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    Esslingen am Neckar, 73730

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    Eutin, 23701

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    Filderstadt, Baden-Wurttemberg, 70794

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    Flensburg, Schleswig-Holstein, 24939

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    Frankfurt am Main, Hesse, 60398

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    Frankfurt am Main, Hesse, 60431

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    Frankfurt am Main, Hesse, 65929

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    Freiburg im Breisgau, 79110

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    Freudenstadt, Baden-Wurttemberg, 72250

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    Friedrichshafen, 88045

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    Friedrichshafen, 88048

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    Fürstenwalde, 15517

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    Fürth, Bavaria, 90766

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    Gengenbach, 77723

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    Georgsmarienhütte, Lower Saxony, 49124

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    Gera, 07548

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    Gerlingen, 70839

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    Goslar, 38642

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    Göttingen, Lower Saxony, 37073

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    Göttingen, 37075

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    Greifswald, 17489

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    Gummersbach, 51643

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    Günzburg, 89312

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    Hagen, North Rhine-Westphalia, 58089

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    Hagen, 58095

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    Haldensleben I, 39340

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    Halle, Saxony-Anhalt, 06110

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    Halle, Saxony-Anhalt, 06120

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    Hamburg, Free and Hanseatic City of Hamburg, 22291

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    Hamburg, Free and Hanseatic City of Hamburg, 22457

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    Hamburg, 20259

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    Hamburg, 20357

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    Hamburg, 21073

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    Hanover, 30159

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    Hanover, 30177

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    Hanover, 30625

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    Hansestadt Salzwedel, Saxony-Anhalt, 29410

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    Heide, 25746

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    Heidelberg, Baden-Wurttemberg, 69115

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    Heidelberg, 69120

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    Heidenheim, Baden-Wurttemberg, 89522

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    Heilbronn, 74078

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    Hennigsdorf, 16761

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    Herdecke, 58313

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    Herrsching am Ammersee, Bavaria, 82211

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    Hildesheim, Lower Saxony, 31134

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    Homburg, 66421

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    Ilsede, Lower Saxony, 31241

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    Itzehoe, 25524

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    Jena, Thuringia, 07740

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    Jena, 07747

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    Kaiserslautern, 67655

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    Karlsruhe, 76133

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    Karlsruhe, 76135

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    Kempten (Allgäu), Bavaria, 87439

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    Kiel, 24103

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    Königs Wusterhausen, Brandenburg, 15711

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    Konstanz, Baden-Wurttemberg, 78464

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    Krefeld, 47805

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    Kronach, Bavaria, 96317

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    Kulmbach, 95326

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    Landsberg am Lech, Bavaria, 86899

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    Langen, Hesse, 63225

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    Lebach, Saarland, 66822

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    Leer, 26789

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    Leipzig, Saxony, 04103

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    Leipzig, 04277

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    Lingen, Lower Saxony, 49808

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    Loerrach, 79539

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    Lübeck, Schleswig-Holstein, 23563

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    Lübeck, 23538

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    Magdeburg, Saxony-Anhalt, 39108

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    Magdeburg, Saxony-Anhalt, 39130

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    Mainz, 55131

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    Mannheim, Baden-Wurttemberg, 68161

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    Mannheim, Baden-Wurttemberg, 68165

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    Marburg, Hesse, 35037

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    Marburg, Hesse, 35043

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    Marktredwitz, 95615

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    Mayen, Rhineland-Palatinate, 56727

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    Memmingen, 87700

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    Moers, 47441

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    Mönchengladbach, North Rhine-Westphalia, 41061

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    Mühlhausen, Thuringia, 99974

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    Munich, Bavaria, 80637

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    Munich, Bavaria, 81241

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    Munich, Bavaria, 81377

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    Munich, Bavaria, 81925

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    Münster, 48145

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    Münster, 48149

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    Mutlangen, 73557

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    Naunhof, 04683

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    Neubrandenburg, 17036

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    Neumarkt in der Oberpfalz, Bavaria, 92318

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    Neumünster, 24534

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    Neuruppin, 16816

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    Neuss, 41462

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    Neustadt an der Weinstraße, Rhineland-Palatinate, 67434

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    Neustadt in Sachsen, Saxony, 01844

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    Nordhausen, Thuringia, 99734

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    Nuremberg, 90403

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    Nuremberg, 90419

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    Nürtingen, Baden-Wurttemberg, 72622

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    Offenburg, 77654

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    Oldenburg, 26121

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    Olpe, North Rhine-Westphalia, 57462

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    Osnabrück, Lower Saxony, 49076

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    Ostfildern, Baden-Wurttemberg, 73760

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    Paderborn, North Rhine-Westphalia, 33098

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    Passau, 94036

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    Pforzheim, Baden-Wurttemberg, 75179

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    Plauen, Saxony, 08525

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    Potsdam, 14467

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    Potsdam, 14482

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    Prien am Chiemsee, Bavaria, 83209

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    Radebeul, Saxony, 01445

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    Ravensburg, Baden-Wurttemberg, 88212

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    Recklinghausen, 45657

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    Regensburg, Bavaria, 93053

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    Regensburg, 93053

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    Remscheid, North Rhine-Westphalia, 42853

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    Remscheid, North Rhine-Westphalia, 42859

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    Rendsburg, Schleswig-Holstein, 24768

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    Reutlingen, Baden-Wurttemberg, 72764

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    Rheine, 48431

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    Rodewisch, Saxony, 08228

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    Rosenheim, Bavaria, 83022

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    Rostock, Mecklenburg-Vorpommern, 18057

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    Rotenburg (Wümme), Lower Saxony, 27356

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    Rüsselsheim am Main, 65428

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    Saalfeld, Thuringia, 07318

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    Saarlouis, 66740

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    Scheibenberg, Saxony, 09481

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    Schkeuditz, Saxony, 04435

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    Schorndorf, 73614

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    Schwäbisch Hall, Baden-Wurttemberg, 74523

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    Schweinfurt, 97422

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    Schwerte, North Rhine-Westphalia, 58239

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    Siegen, North Rhine-Westphalia, 57072

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    Siegen, 57074

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    Sigmaringen, 72488

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    Singen, 78224

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    Sinsheim, 74889

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    Soest, 59494

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    Speyer, Rhineland-Palatinate, 67346

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    Stendal, Saxony-Anhalt, 39576

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    Stendal, 39576

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    Stralsund, 18439

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    Stuttgart, 70174

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    Stuttgart, 70176

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    Stuttgart, 70199

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    Suhl, 98527

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    Torgau, 04860

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    Traunstein, Bavaria, 83278

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    Traunstein, 83278

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    Trier, 54290

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    Troisdorf, North Rhine-Westphalia, 53840

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    Tübingen, 72076

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    Twistringen, Lower Saxony, 27239

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    Ulm, Bavaria, 89073

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    Ulm, 89081

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    Velbert, North Rhine-Westphalia, 42551

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    Villingen-Schwenningen, Baden-Wurttemberg, 78052

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    Waldkirchen, 94065

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    Waldmuenchen, Bavaria, 93449

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    Waldsassen, 95652

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    Walsrode, 29664

    Recruiting

  • Novartis Investigative Site

    Weiden in Der Oberpfalz, Bavaria, 92637

    Recruiting

  • Novartis Investigative Site

    Weilheim, Bavaria, 82362

    Recruiting

  • Novartis Investigative Site

    Weinheim, 69469

    Recruiting

  • Novartis Investigative Site

    Werdau, 08412

    Recruiting

  • Novartis Investigative Site

    Wernigerode, 38855

    Recruiting

  • Novartis Investigative Site

    Wesel, 46485

    Recruiting

  • Novartis Investigative Site

    Westerstede, Lower Saxony, 26655

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  • Novartis Investigative Site

    Wetzlar, 35578

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  • Novartis Investigative Site

    Wiesbaden, Hesse, 65189

    Recruiting

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65199

    Recruiting

  • Novartis Investigative Site

    Winnenden, Baden-Wurttemberg, 71364

    Recruiting

  • Novartis Investigative Site

    Winsen, Lower Saxony, 21423

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  • Novartis Investigative Site

    Witten, 58452

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  • Novartis Investigative Site

    Wolfenbüttel, Lower Saxony, 38304

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  • Novartis Investigative Site

    Worms, 67550

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  • Novartis Investigative Site

    Wunstorf, Lower Saxony, 31515

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  • Novartis Investigative Site

    Würzburg, Bavaria, 97070

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  • Novartis Investigative Site

    Würzburg, 97080

    Recruiting

  • Novartis Investigative Site

    Zittau, Saxony, 02763

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Austria12 sites, 12 recruiting

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  • Novartis Investigative Site

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  • Novartis Investigative Site

    Klagenfurt, 9020

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  • Novartis Investigative Site

    Leoben, 8700

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  • Novartis Investigative Site

    Linz, Upper Austria, 4010

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  • Novartis Investigative Site

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    Steyr, 4400

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    Vienna, 1090

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    Vienna, 1130

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  • Novartis Investigative Site

    Vienna, 1160

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  • Novartis Investigative Site

    Wiener Neustadt, Lower Austria, 2700

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Other trials in Austria

About this study

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

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.

Read the detailed description

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 aromatase inhibitor (AI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the current effective local 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 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.

Being tested
ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, ET mono ± LHRH
Keywords
Non-interventional study, NIS, breast cancer, early breast cancer, HR+, HER-, ribociclib, real world evidence, adjuvant therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ribociclib + AI ± LHRHDrug

    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 ± LHRHDrug

    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 ± LHRHDrug

    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.

Study groups in NCT06830720
Study groupRoleWhat they receive
ribociclibribociclib + AI ± LHRH
Receives: Drug: ribociclib + AI ± LHRH
abemaciclibabemaciclib + ET ± LHRH
Receives: Drug: abemaciclib + ET ± LHRH
ET monoET mono ± LHRH
Receives: Drug: ET mono ± LHRH

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 36 months

Secondary outcomes (28)

  1. Number of participants per Baseline parameters

    Description of available baseline characteristics (e.g. medical history, gender, menopausal status, disease characteristics, laboratory values, socio-economic status, genetic profile, etc.) by treatment cohorts

    Measured: baseline

  2. Reasons for treatment decision by treating physician

    Reason for treatment decision documented by the treating physician

    Measured: baseline

  3. Patients' individual perception of risk of recurrence and treatment decision

    Patients' individual perception of risk of recurrence and treatment decision assessed by questionnaire at baseline. The questionnaire is provided in two versions, with one version containing 6 items (applicable for the ET mono cohort), and the other version containing 11 items (applicable for ribociclib and abemaciclib cohorts). Responses are primarily given by selecting from predefined options, with some questions allowing multiple answers or prioritization. The scales and response options are designed to reflect individual preferences, concerns, and decision-making processes of patients. Higher scores on the importance scale indicate a stronger motivation to reduce recurrence risk

    Measured: baseline

  4. Invasive disease-free survival (iDFS) (ribociclib cohort)

    iDFS using STEEP criteria. 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).

    Measured: 12 and 24 months

  5. Invasive breast cancer-free survival (iBCFS) (ribociclib cohort)

    iBCFS using STEEP criteria. iBCFS 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), or contralateral invasive BC.

    Measured: 12, 24 and 36 months

  6. Recurrence-free survival (RFS) (ribociclib cohort)

    RFS using STEEP criteria. RFS 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, or death (any cause).

    Measured: 12, 24 and 36 months

  7. Distant disease-free survival (DDFS) (ribociclib cohort)

    DDFS using STEEP criteria. DDFS is defined as the time from study start to the date of the first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).

    Measured: 12, 24 and 36 months

  8. Incidence and severity of adverse events (ribociclib cohort)

    Incidence and severity of adverse events

    Measured: up to 36 months

  9. Dose modification rates (ribociclib cohort)

    Proportion of patients with dose modification and underlying cause

    Measured: up to 36 months

  10. Treatment interruption rates (ribociclib cohort)

    Proportion of patients with treatment interruption and underlying cause

    Measured: up to 36 months

  11. Discontinuation rates (ribociclib cohort)

    Proportion of patients who discontinued treatment and underlying cause

    Measured: up to 36 months

  12. Time to discontinuation (TTD) (ribociclib cohort)

    Time from treatment start to permanent treatment discontinuation

    Measured: up to 36 months

  13. Quality of life by EORTC QLQ-C30 (ribociclib and abemaciclib cohorts)

    Changes from baseline as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30. The EORTC QLQ-C30 is a participant completed 30 item questionnaire that is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, six single items and a GHS/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: up to 39 months

  14. Quality of life by EORTC QLQ-BR42 (ribociclib and abemaciclib cohorts)

    Changes from baseline as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-BR42. The Breast Cancer Module EORTC QLQ-BR42 is a 42 item instrument designed to measure quality of life in breast cancer participants. It includes three functional scales, six symptom scales and three single items. All the scales and single item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: up to 39 months

  15. Quality of life by HADS D (ribociclib and abemaciclib cohorts)

    Changes from baseline as assessed by the Hospital Anxiety and Depression Scale (HADS D). The HADS is a participant completed fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.

    Measured: up to 39 months

  16. Participant compliance as assessed by the Medication Adherence Report Scale (MARS-D) (ribociclib and abemaciclib cohorts)

    Medication Adherence Report Scale (MARS-D) questionnaire is a 5-item questionnaire measuring non-adherence. Each item is ranging from "never" (5 points) to "always" (1 point), with a total score 5-25 where higher scores indicate better compliance.

    Measured: up to 36 months

  17. Participant compliance as assessed by a physician adherence rating (ribociclib cohort)

    Participant compliance as assessed by a physician adherence rated as very good, good, moderate, or poor.

    Measured: up to 36 months

  18. Participant compliance as assessed by neutrophil count (ribociclib cohort)

    Participant compliance as assessed by neutrophil count.

    Measured: up to 36 months

  19. Impact of type and change of treatment facility and health care professionals involved in treatment management on participant compliance assessed by MARS-D (ribociclib cohort)

    Medication Adherence Report Scale (MARS-D) questionnaire is a 5-item questionnaire measuring non-adherence. Each item is ranging from "never" (5 points) to "always" (1 point), with a total score 5-25 where higher scores indicate better compliance.

    Measured: up to 36 months

  20. Impact of digital health solutions applied in clinical routine on participant compliance assessed by MARS-D (ribociclib cohort)

    Medication Adherence Report Scale (MARS-D) questionnaire is a 5-item questionnaire measuring non-adherence. Each item is ranging from "never" (5 points) to "always" (1 point), with a total score 5-25 where higher scores indicate better compliance.

    Measured: up to 36 months

  21. Socio-economic status of participants measured by WPAI-GH (ribociclib and abemaciclib cohorts)

    The Work Productivity and Activity Impairment - General Health questionnaire (WPAI-GH) is a participant completed 6 item questionnaire which addresses absenteeism, presenteeism, overall work productivity loss, and activity impairment for the 7 days prior to the assessment. WPAI outcomes are presented as impairment percentages (range goes from 0 to 100 with a higher percentage indicating greater impairment and less productivity).

    Measured: up to 39 months

  22. Number of participants per reason for treatment discontinuation (ribociclib and abemaciclib cohorts)

    Reported reasons for treatment discontinuation

    Measured: up to 39 months

  23. Type of subsequent anti-neoplastic therapies (ribociclib and abemaciclib cohorts)

    Type of subsequent anti-neoplastic therapies will be recorded

    Measured: up to 39 months

  24. Time to subsequent anti-neoplastic therapy (ribociclib and abemaciclib cohorts)

    Time from study start to first subsequent anti-neoplastic therapy

    Measured: up to 39 months

  25. Impact of an active participation of the participant in the treatment decision on subsequent participant compliance measured by MARS-D (ribociclib cohort)

    Participant compliance assessed by MARS-D and active participation of the participant in the treatment decision assessed by the questionnaire "Fragebogen zur partizipativen Entscheidungsfindung aus Participantensicht" (PEF-FB-9) and "Fragebogen zur partizipativen Entscheidungsfindung aus Sicht des Arztes"(PEF-FB-Doc) at baseline.

    The MARS-D is a 5-item questionnaire measuring non-adherence with a total score of 5-25 where higher scores indicate better compliance.

    The PEF-FB-9 is a participant completed 9 item questionnaire for participant participation in decision-making. The 9 items are rated on a 6-point scale with endpoints ranging from "does not apply at all" to "applies completely", summed up and transformed into a scale from 0 to 100. The higher the total score, the higher the perceived degree of participation.

    The PEF-FB-Doc is the physician version of the PEF-FB-9.

    The correlation between participation on treatment decisions and participant compliance will be presented.

    Measured: up to 36 months

  26. Impact of participants' fear of cancer recurrence on participant compliance measured by MARS-D (ribociclib cohort)

    Participant compliance assessed by MARS-D and participants' fear of cancer recurrence assessed by the Fear of Cancer Recurrence (FCR)-1 questionnaire.

    The MARS-D questionnaire is a 5-item questionnaire measuring non-adherence. Each item is ranging from "never" (5 points) to "always" (1 point), with a total score 5-25 where higher scores indicate better compliance.

    The FCR-1 is a participant completed 1 item questionnaire asking the participant to describe their subjective level of fear of cancer recurrence at the given time on a scale from 0 to 100 with 100 being the greatest fear.

    The correlation between participants' fear of recurrence and participant compliance will be presented.

    Measured: up to 36 months

  27. Participants' expectations regarding therapy, side effects and management (ribociclib and abemaciclib cohorts)

    Treatment expectation assessed by a questionnaire containing 5 questions with each 5-7 ordinal answer categories with the same directionality on participants' expectations regarding therapy, side effects and management

    Measured: baseline

  28. Participants' treatment satisfaction (ribociclib and abemaciclib cohorts)

    Treatment satisfaction assessed by a questionnaire containing 5 questions with each 5-7 ordinal answer categories with the same directionality on treatment satisfaction

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start20 Feb 2025
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06830720
Sponsor's protocol ID
CLEE011O1DE01
Acronym
CAROLEEN
Status last verified
Jul 2026
First submitted
4 Feb 2025
Last updated
30 Jul 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Novartis Pharmaceuticals at 287 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 287 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06830720.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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