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)

May 28, 2026 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Recruiting

Conditions

Breast Neoplasms

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Novartis Pharmaceuticals
Phone Number: +41613241111
Email: novartis.email@novartis.com

Study Contact Backup

Name: Novartis Pharmaceuticals

Study Locations

Austria
- - Graz, Austria, 8036
    - Recruiting
    - Novartis Investigative Site
  - Klagenfurt, Austria, 9020
    - Recruiting
    - Novartis Investigative Site
  - Leoben, Austria, A 8700
    - Recruiting
    - Novartis Investigative Site
  - Schwaz, Austria, 6130
    - Recruiting
    - Novartis Investigative Site
  - Steyr, Austria, 4400
    - Recruiting
    - Novartis Investigative Site
  - Vienna, Austria, 1090
    - Recruiting
    - Novartis Investigative Site
  - Vienna, Austria, 1140
    - Recruiting
    - Novartis Investigative Site
  - Vienna, Austria, A-1130
    - Recruiting
    - Novartis Investigative Site
  - Vienna, Austria, 1160
    - Recruiting
    - Novartis Investigative Site
- Lower Austria
  - Wiener Neustadt, Lower Austria, Austria, 2700
    - Recruiting
    - Novartis Investigative Site
- Tyrol
  - Innsbruck, Tyrol, Austria, 6020
    - Recruiting
    - Novartis Investigative Site
- Upper Austria
  - Linz, Upper Austria, Austria, 4010
    - Recruiting
    - Novartis Investigative Site
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - Novartis Investigative Site
  - Amberg, Germany, 92224
    - Recruiting
    - Novartis Investigative Site
  - Apolda, Germany, 99510
    - Recruiting
    - Novartis Investigative Site
  - Arnsberg, Germany, 59759
    - Recruiting
    - Novartis Investigative Site
  - Augsburg, Germany, 86150
    - Recruiting
    - Novartis Investigative Site
  - Bad Friedrichshall, Germany, 74177
    - Recruiting
    - Novartis Investigative Site
  - Bad Kreuznach, Germany, 55543
    - Recruiting
    - Novartis Investigative Site
  - Bad Langensalza, Germany, 99947
    - Recruiting
    - Novartis Investigative Site
  - Bad Mergentheim, Germany, 97980
    - Recruiting
    - Novartis Investigative Site
  - Bad Reichenhall, Germany, 83435
    - Recruiting
    - Novartis Investigative Site
  - Bad Saarow, Germany, 15526
    - Recruiting
    - Novartis Investigative Site
  - Bad Soden, Germany, 65812
    - Recruiting
    - Novartis Investigative Site
  - Balingen, Germany, 72336
    - Recruiting
    - Novartis Investigative Site
  - Bautzen, Germany, 02625
    - Recruiting
    - Novartis Investigative Site
  - Bayreuth, Germany, 95445
    - Recruiting
    - Novartis Investigative Site
  - Berlin, Germany, 10367
    - Recruiting
    - Novartis Investigative Site
  - Berlin, Germany, 14169
    - Recruiting
    - Novartis Investigative Site
  - Berlin, Germany, 10715
    - Recruiting
    - Novartis Investigative Site
  - Berlin, Germany, 12552
    - Recruiting
    - Novartis Investigative Site
  - Berlin, Germany, 14195
    - Recruiting
    - Novartis Investigative Site
  - Berlin, Germany, 13589
    - Recruiting
    - Novartis Investigative Site
  - Biberach, Germany, 88400
    - Recruiting
    - Novartis Investigative Site
  - Bochum, Germany, 44787
    - Recruiting
    - Novartis Investigative Site
  - Bonn, Germany, 53105
    - Recruiting
    - Novartis Investigative Site
  - Bonn, Germany, 53113
    - Recruiting
    - Novartis Investigative Site
  - Bonn, Germany, 53123
    - Recruiting
    - Novartis Investigative Site
  - Bottrop, Germany, 46236
    - Recruiting
    - Novartis Investigative Site
  - Brandenburg, Germany, 14770
    - Recruiting
    - Novartis Investigative Site
  - Bremen, Germany, 28205
    - Recruiting
    - Novartis Investigative Site
  - Bremerhaven, Germany, 27574
    - Recruiting
    - Novartis Investigative Site
  - Bruchsal, Germany, 76646
    - Recruiting
    - Novartis Investigative Site
  - Böblingen, Germany, 71032
    - Recruiting
    - Novartis Investigative Site
  - Celle, Germany, 29223
    - Recruiting
    - Novartis Investigative Site
  - Chemnitz, Germany, 09113
    - Recruiting
    - Novartis Investigative Site
  - Chemnitz, Germany, 09117
    - Recruiting
    - Novartis Investigative Site
  - Coburg, Germany, 96450
    - Recruiting
    - Novartis Investigative Site
  - Cologne, Germany, 50935
    - Recruiting
    - Novartis Investigative Site
  - Dachau, Germany, 85221
    - Recruiting
    - Novartis Investigative Site
  - Dessau, Germany, 06847
    - Recruiting
    - Novartis Investigative Site
  - Dorfen, Germany, 84405
    - Recruiting
    - Novartis Investigative Site
  - Dresden, Germany, 01307
    - Recruiting
    - Novartis Investigative Site
  - Dresden, Germany, 01127
    - Recruiting
    - Novartis Investigative Site
  - Duisburg, Germany, 47053
    - Recruiting
    - Novartis Investigative Site
  - Düsseldorf, Germany, 40235
    - Recruiting
    - Novartis Investigative Site
  - Eggenfelden, Germany, 84307
    - Recruiting
    - Novartis Investigative Site
  - Ehingen, Germany, 89584
    - Recruiting
    - Novartis Investigative Site
  - Ehrenfriedersdorf, Germany, 09427
    - Recruiting
    - Novartis Investigative Site
  - Eisenach, Germany, 99817
    - Recruiting
    - Novartis Investigative Site
  - Erding, Germany, 85435
    - Recruiting
    - Novartis Investigative Site
  - Erfurt, Germany, 99085
    - Recruiting
    - Novartis Investigative Site
  - Erfurt, Germany, 99084
    - Recruiting
    - Novartis Investigative Site
  - Eschweiler, Germany, 52249
    - Recruiting
    - Novartis Investigative Site
  - Essen, Germany, 45147
    - Recruiting
    - Novartis Investigative Site
  - Essen, Germany, 45136
    - Recruiting
    - Novartis Investigative Site
  - Esslingen am Neckar, Germany, 73730
    - Recruiting
    - Novartis Investigative Site
  - Eutin, Germany, 23701
    - Recruiting
    - Novartis Investigative Site
  - Freiburg im Breisgau, Germany, 79110
    - Recruiting
    - Novartis Investigative Site
  - Friedrichshafen, Germany, 88045
    - Recruiting
    - Novartis Investigative Site
  - Friedrichshafen, Germany, 88048
    - Recruiting
    - Novartis Investigative Site
  - Fürstenwalde, Germany, 15517
    - Recruiting
    - Novartis Investigative Site
  - Gengenbach, Germany, 77723
    - Recruiting
    - Novartis Investigative Site
  - Gera, Germany, 07548
    - Recruiting
    - Novartis Investigative Site
  - Gerlingen, Germany, 70839
    - Recruiting
    - Novartis Investigative Site
  - Goslar, Germany, 38642
    - Recruiting
    - Novartis Investigative Site
  - Greifswald, Germany, 17489
    - Recruiting
    - Novartis Investigative Site
  - Gummersbach, Germany, 51643
    - Recruiting
    - Novartis Investigative Site
  - Göttingen, Germany, 37075
    - Recruiting
    - Novartis Investigative Site
  - Günzburg, Germany, 89312
    - Recruiting
    - Novartis Investigative Site
  - Hagen, Germany, 58095
    - Recruiting
    - Novartis Investigative Site
  - Haldensleben I, Germany, 39340
    - Recruiting
    - Novartis Investigative Site
  - Hamburg, Germany, 21073
    - Recruiting
    - Novartis Investigative Site
  - Hamburg, Germany, 20259
    - Recruiting
    - Novartis Investigative Site
  - Hamburg, Germany, 20357
    - Recruiting
    - Novartis Investigative Site
  - Hanover, Germany, 30177
    - Recruiting
    - Novartis Investigative Site
  - Hanover, Germany, 30159
    - Recruiting
    - Novartis Investigative Site
  - Hanover, Germany, 30625
    - Recruiting
    - Novartis Investigative Site
  - Heide, Germany, 25746
    - Recruiting
    - Novartis Investigative Site
  - Heidelberg, Germany, 69120
    - Recruiting
    - Novartis Investigative Site
  - Heilbronn, Germany, 74078
    - Recruiting
    - Novartis Investigative Site
  - Hennigsdorf, Germany, 16761
    - Recruiting
    - Novartis Investigative Site
  - Herdecke, Germany, 58313
    - Recruiting
    - Novartis Investigative Site
  - Homburg, Germany, 66421
    - Recruiting
    - Novartis Investigative Site
  - Itzehoe, Germany, 25524
    - Recruiting
    - Novartis Investigative Site
  - Jena, Germany, 07747
    - Recruiting
    - Novartis Investigative Site
  - Kaiserslautern, Germany, 67655
    - Recruiting
    - Novartis Investigative Site
  - Karlsruhe, Germany, 76133
    - Recruiting
    - Novartis Investigative Site
  - Karlsruhe, Germany, 76135
    - Recruiting
    - Novartis Investigative Site
  - Kiel, Germany, 24103
    - Recruiting
    - Novartis Investigative Site
  - Krefeld, Germany, 47805
    - Recruiting
    - Novartis Investigative Site
  - Kulmbach, Germany, 95326
    - Recruiting
    - Novartis Investigative Site
  - Leer, Germany, 26789
    - Recruiting
    - Novartis Investigative Site
  - Leipzig, Germany, 04277
    - Recruiting
    - Novartis Investigative Site
  - Loerrach, Germany, 79539
    - Recruiting
    - Novartis Investigative Site
  - Lübeck, Germany, 23538
    - Recruiting
    - Novartis Investigative Site
  - Mainz, Germany, 55131
    - Recruiting
    - Novartis Investigative Site
  - Marktredwitz, Germany, 95615
    - Recruiting
    - Novartis Investigative Site
  - Memmingen, Germany, 87700
    - Recruiting
    - Novartis Investigative Site
  - Moers, Germany, 47441
    - Recruiting
    - Novartis Investigative Site
  - Mutlangen, Germany, 73557
    - Recruiting
    - Novartis Investigative Site
  - Münster, Germany, 48145
    - Recruiting
    - Novartis Investigative Site
  - Münster, Germany, 48149
    - Recruiting
    - Novartis Investigative Site
  - Naunhof, Germany, 04683
    - Recruiting
    - Novartis Investigative Site
  - Neubrandenburg, Germany, 17036
    - Recruiting
    - Novartis Investigative Site
  - Neumünster, Germany, 24534
    - Recruiting
    - Novartis Investigative Site
  - Neuss, Germany, 41462
    - Recruiting
    - Novartis Investigative Site
  - Nuremberg, Germany, 90419
    - Recruiting
    - Novartis Investigative Site
  - Nuremberg, Germany, 90403
    - Recruiting
    - Novartis Investigative Site
  - Offenburg, Germany, 77654
    - Recruiting
    - Novartis Investigative Site
  - Oldenburg, Germany, 26121
    - Recruiting
    - Novartis Investigative Site
  - Passau, Germany, 94036
    - Recruiting
    - Novartis Investigative Site
  - Potsdam, Germany, 14482
    - Recruiting
    - Novartis Investigative Site
  - Regensburg, Germany, 93053
    - Recruiting
    - Novartis Investigative Site
  - Rheine, Germany, 48431
    - Recruiting
    - Novartis Investigative Site
  - Rüsselsheim am Main, Germany, 65428
    - Recruiting
    - Novartis Investigative Site
  - Saarlouis, Germany, 66740
    - Recruiting
    - Novartis Investigative Site
  - Schorndorf, Germany, 73614
    - Recruiting
    - Novartis Investigative Site
  - Schweinfurt, Germany, 97422
    - Recruiting
    - Novartis Investigative Site
  - Siegen, Germany, 57074
    - Recruiting
    - Novartis Investigative Site
  - Sigmaringen, Germany, 72488
    - Recruiting
    - Novartis Investigative Site
  - Singen, Germany, 78224
    - Recruiting
    - Novartis Investigative Site
  - Sinsheim, Germany, 74889
    - Recruiting
    - Novartis Investigative Site
  - Soest, Germany, 59494
    - Recruiting
    - Novartis Investigative Site
  - Stendal, Germany, 39576
    - Recruiting
    - Novartis Investigative Site
  - Stralsund, Germany, 18439
    - Recruiting
    - Novartis Investigative Site
  - Stuttgart, Germany, 70174
    - Recruiting
    - Novartis Investigative Site
  - Stuttgart, Germany, 70176
    - Recruiting
    - Novartis Investigative Site
  - Stuttgart, Germany, 70199
    - Recruiting
    - Novartis Investigative Site
  - Suhl, Germany, 98527
    - Recruiting
    - Novartis Investigative Site
  - Torgau, Germany, 04860
    - Recruiting
    - Novartis Investigative Site
  - Traunstein, Germany, 83278
    - Recruiting
    - Novartis Investigative Site
  - Trier, Germany, 54290
    - Recruiting
    - Novartis Investigative Site
  - Tübingen, Germany, 72076
    - Recruiting
    - Novartis Investigative Site
  - Ulm, Germany, 89081
    - Recruiting
    - Novartis Investigative Site
  - Waldkirchen, Germany, 94065
    - Recruiting
    - Novartis Investigative Site
  - Waldsassen, Germany, 95652
    - Recruiting
    - Novartis Investigative Site
  - Walsrode, Germany, 29664
    - Recruiting
    - Novartis Investigative Site
  - Weinheim, Germany, 69469
    - Recruiting
    - Novartis Investigative Site
  - Werdau, Germany, 08412
    - Recruiting
    - Novartis Investigative Site
  - Wernigerode, Germany, 38855
    - Recruiting
    - Novartis Investigative Site
  - Wesel, Germany, 46485
    - Recruiting
    - Novartis Investigative Site
  - Wetzlar, Germany, 35578
    - Recruiting
    - Novartis Investigative Site
  - Witten, Germany, 58452
    - Recruiting
    - Novartis Investigative Site
  - Worms, Germany, 67550
    - Recruiting
    - Novartis Investigative Site
  - Würzburg, Germany, 97080
    - Recruiting
    - Novartis Investigative Site
- Baden-Wurttemberg
  - Baden-Baden, Baden-Wurttemberg, Germany, 76532
    - Recruiting
    - Novartis Investigative Site
  - Filderstadt, Baden-Wurttemberg, Germany, 70794
    - Recruiting
    - Novartis Investigative Site
  - Freudenstadt, Baden-Wurttemberg, Germany, 72250
    - Recruiting
    - Novartis Investigative Site
  - Heidelberg, Baden-Wurttemberg, Germany, 69115
    - Recruiting
    - Novartis Investigative Site
  - Heidenheim, Baden-Wurttemberg, Germany, 89522
    - Recruiting
    - Novartis Investigative Site
  - Konstanz, Baden-Wurttemberg, Germany, 78464
    - Recruiting
    - Novartis Investigative Site
  - Mannheim, Baden-Wurttemberg, Germany, 68161
    - Recruiting
    - Novartis Investigative Site
  - Mannheim, Baden-Wurttemberg, Germany, 68165
    - Recruiting
    - Novartis Investigative Site
  - Nürtingen, Baden-Wurttemberg, Germany, 72622
    - Recruiting
    - Novartis Investigative Site
  - Ostfildern, Baden-Wurttemberg, Germany, 73760
    - Recruiting
    - Novartis Investigative Site
  - Pforzheim, Baden-Wurttemberg, Germany, 75179
    - Recruiting
    - Novartis Investigative Site
  - Ravensburg, Baden-Wurttemberg, Germany, 88212
    - Recruiting
    - Novartis Investigative Site
  - Reutlingen, Baden-Wurttemberg, Germany, 72764
    - Recruiting
    - Novartis Investigative Site
  - Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523
    - Recruiting
    - Novartis Investigative Site
  - Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78052
    - Recruiting
    - Novartis Investigative Site
  - Winnenden, Baden-Wurttemberg, Germany, 71364
    - Recruiting
    - Novartis Investigative Site
- Bavaria
  - Altötting, Bavaria, Germany, 84503
    - Recruiting
    - Novartis Investigative Site
  - Ansbach, Bavaria, Germany, 91522
    - Recruiting
    - Novartis Investigative Site
  - Augsburg, Bavaria, Germany, 86157
    - Recruiting
    - Novartis Investigative Site
  - Bamberg, Bavaria, Germany, 96049
    - Recruiting
    - Novartis Investigative Site
  - Bayreuth, Bavaria, Germany, 95445
    - Recruiting
    - Novartis Investigative Site
  - Dillingen an der Donau, Bavaria, Germany, 89407
    - Recruiting
    - Novartis Investigative Site
  - Donauwörth, Bavaria, Germany, 86609
    - Recruiting
    - Novartis Investigative Site
  - Ebersberg, Bavaria, Germany, 85560
    - Recruiting
    - Novartis Investigative Site
  - Erlangen, Bavaria, Germany, 91054
    - Recruiting
    - Novartis Investigative Site
  - Fürth, Bavaria, Germany, 90766
    - Recruiting
    - Novartis Investigative Site
  - Herrsching am Ammersee, Bavaria, Germany, 82211
    - Recruiting
    - Novartis Investigative Site
  - Kempten (Allgäu), Bavaria, Germany, 87439
    - Recruiting
    - Novartis Investigative Site
  - Kronach, Bavaria, Germany, 96317
    - Recruiting
    - Novartis Investigative Site
  - Landsberg am Lech, Bavaria, Germany, 86899
    - Recruiting
    - Novartis Investigative Site
  - Munich, Bavaria, Germany, 81241
    - Recruiting
    - Novartis Investigative Site
  - Munich, Bavaria, Germany, 81377
    - Recruiting
    - Novartis Investigative Site
  - Munich, Bavaria, Germany, 80637
    - Recruiting
    - Novartis Investigative Site
  - Munich, Bavaria, Germany, 81925
    - Recruiting
    - Novartis Investigative Site
  - Neumarkt in der Oberpfalz, Bavaria, Germany, 92318
    - Recruiting
    - Novartis Investigative Site
  - Prien am Chiemsee, Bavaria, Germany, 83209
    - Recruiting
    - Novartis Investigative Site
  - Regensburg, Bavaria, Germany, 93053
    - Recruiting
    - Novartis Investigative Site
  - Rosenheim, Bavaria, Germany, 83022
    - Recruiting
    - Novartis Investigative Site
  - Traunstein, Bavaria, Germany, 83278
    - Recruiting
    - Novartis Investigative Site
  - Ulm, Bavaria, Germany, 89073
    - Recruiting
    - Novartis Investigative Site
  - Waldmuenchen, Bavaria, Germany, 93449
    - Recruiting
    - Novartis Investigative Site
  - Weiden in Der Oberpfalz, Bavaria, Germany, 92637
    - Recruiting
    - Novartis Investigative Site
  - Weilheim, Bavaria, Germany, 82362
    - Recruiting
    - Novartis Investigative Site
  - Würzburg, Bavaria, Germany, 97070
    - Recruiting
    - Novartis Investigative Site
- Brandenburg
  - Brandenburg an der Havel, Brandenburg, Germany, 14770
    - Recruiting
    - Novartis Investigative Site
  - Cottbus, Brandenburg, Germany, 03048
    - Recruiting
    - Novartis Investigative Site
  - Königs Wusterhausen, Brandenburg, Germany, 15711
    - Recruiting
    - Novartis Investigative Site
- Free Hanseatic City of Bremen
  - Bremen, Free Hanseatic City of Bremen, Germany, 28209
    - Recruiting
    - Novartis Investigative Site
  - Bremen, Free Hanseatic City of Bremen, Germany, 28239
    - Recruiting
    - Novartis Investigative Site
  - Bremerhaven, Free Hanseatic City of Bremen, Germany, 27576
    - Recruiting
    - Novartis Investigative Site
- Free and Hanseatic City of Hamburg
  - Hamburg, Free and Hanseatic City of Hamburg, Germany, 22291
    - Recruiting
    - Novartis Investigative Site
  - Hamburg, Free and Hanseatic City of Hamburg, Germany, 22457
    - Recruiting
    - Novartis Investigative Site
- Hesse
  - Bad Homburg, Hesse, Germany, 61352
    - Recruiting
    - Novartis Investigative Site
  - Bad Nauheim, Hesse, Germany, 61231
    - Recruiting
    - Novartis Investigative Site
  - Frankfurt am Main, Hesse, Germany, 60431
    - Recruiting
    - Novartis Investigative Site
  - Frankfurt am Main, Hesse, Germany, 60398
    - Recruiting
    - Novartis Investigative Site
  - Frankfurt am Main, Hesse, Germany, 65929
    - Recruiting
    - Novartis Investigative Site
  - Langen, Hesse, Germany, 63225
    - Recruiting
    - Novartis Investigative Site
  - Marburg, Hesse, Germany, 35037
    - Recruiting
    - Novartis Investigative Site
  - Marburg, Hesse, Germany, 35043
    - Recruiting
    - Novartis Investigative Site
  - Wiesbaden, Hesse, Germany, 65189
    - Recruiting
    - Novartis Investigative Site
  - Wiesbaden, Hesse, Germany, 65199
    - Recruiting
    - Novartis Investigative Site
- Lower Saxony
  - Braunschweig, Lower Saxony, Germany, 38100
    - Recruiting
    - Novartis Investigative Site
  - Buchholz Nordheide, Lower Saxony, Germany, 21244
    - Recruiting
    - Novartis Investigative Site
  - Georgsmarienhütte, Lower Saxony, Germany, 49124
    - Recruiting
    - Novartis Investigative Site
  - Göttingen, Lower Saxony, Germany, 37073
    - Recruiting
    - Novartis Investigative Site
  - Hildesheim, Lower Saxony, Germany, 31134
    - Recruiting
    - Novartis Investigative Site
  - Ilsede, Lower Saxony, Germany, 31241
    - Recruiting
    - Novartis Investigative Site
  - Lingen, Lower Saxony, Germany, 49808
    - Recruiting
    - Novartis Investigative Site
  - Osnabrück, Lower Saxony, Germany, 49076
    - Recruiting
    - Novartis Investigative Site
  - Rotenburg (Wümme), Lower Saxony, Germany, 27356
    - Recruiting
    - Novartis Investigative Site
  - Twistringen, Lower Saxony, Germany, 27239
    - Recruiting
    - Novartis Investigative Site
  - Westerstede, Lower Saxony, Germany, 26655
    - Recruiting
    - Novartis Investigative Site
  - Winsen, Lower Saxony, Germany, 21423
    - Recruiting
    - Novartis Investigative Site
  - Wolfenbüttel, Lower Saxony, Germany, 38304
    - Recruiting
    - Novartis Investigative Site
  - Wunstorf, Lower Saxony, Germany, 31515
    - Recruiting
    - Novartis Investigative Site
- Mecklenburg-Vorpommern
  - Rostock, Mecklenburg-Vorpommern, Germany, 18057
    - Recruiting
    - Novartis Investigative Site
- North Rhine-Westphalia
  - Aachen, North Rhine-Westphalia, Germany, 52066
    - Recruiting
    - Novartis Investigative Site
  - Bergisch Gladbach, North Rhine-Westphalia, Germany, 51465
    - Recruiting
    - Novartis Investigative Site
  - Bielefeld, North Rhine-Westphalia, Germany, 33604
    - Recruiting
    - Novartis Investigative Site
  - Bielefeld, North Rhine-Westphalia, Germany, 33615
    - Recruiting
    - Novartis Investigative Site
  - Bochum, North Rhine-Westphalia, Germany, 44791
    - Recruiting
    - Novartis Investigative Site
  - Bonn, North Rhine-Westphalia, Germany, 53113
    - Recruiting
    - Novartis Investigative Site
  - Bonn, North Rhine-Westphalia, Germany, 53177
    - Recruiting
    - Novartis Investigative Site
  - Cologne, North Rhine-Westphalia, Germany, 50937
    - Recruiting
    - Novartis Investigative Site
  - Cologne, North Rhine-Westphalia, Germany, 50679
    - Recruiting
    - Novartis Investigative Site
  - Dortmund, North Rhine-Westphalia, Germany, 44137
    - Recruiting
    - Novartis Investigative Site
  - Düsseldorf, North Rhine-Westphalia, Germany, 40217
    - Recruiting
    - Novartis Investigative Site
  - Düsseldorf, North Rhine-Westphalia, Germany, 40225
    - Recruiting
    - Novartis Investigative Site
  - Düsseldorf, North Rhine-Westphalia, Germany, 40625
    - Recruiting
    - Novartis Investigative Site
  - Mönchengladbach, North Rhine-Westphalia, Germany, 41061
    - Recruiting
    - Novartis Investigative Site
  - Olpe, North Rhine-Westphalia, Germany, 57462
    - Recruiting
    - Novartis Investigative Site
  - Paderborn, North Rhine-Westphalia, Germany, 33098
    - Recruiting
    - Novartis Investigative Site
  - Remscheid, North Rhine-Westphalia, Germany, 42859
    - Recruiting
    - Novartis Investigative Site
  - Remscheid, North Rhine-Westphalia, Germany, 42853
    - Withdrawn
    - Novartis Investigative Site
  - Schwerte, North Rhine-Westphalia, Germany, 58239
    - Recruiting
    - Novartis Investigative Site
  - Siegen, North Rhine-Westphalia, Germany, 57072
    - Recruiting
    - Novartis Investigative Site
  - Troisdorf, North Rhine-Westphalia, Germany, 53840
    - Recruiting
    - Novartis Investigative Site
  - Velbert, North Rhine-Westphalia, Germany, 42551
    - Recruiting
    - Novartis Investigative Site
- Rhineland-Palatinate
  - Mayen, Rhineland-Palatinate, Germany, 56727
    - Recruiting
    - Novartis Investigative Site
  - Neustadt an der Weinstraße, Rhineland-Palatinate, Germany, 67434
    - Recruiting
    - Novartis Investigative Site
  - Speyer, Rhineland-Palatinate, Germany, 67346
    - Recruiting
    - Novartis Investigative Site
- Saarland
  - Lebach, Saarland, Germany, 66822
    - Recruiting
    - Novartis Investigative Site
- Saxony
  - Borna, Saxony, Germany, 04552
    - Recruiting
    - Novartis Investigative Site
  - Dresden, Saxony, Germany, 01307
    - Recruiting
    - Novartis Investigative Site
  - Leipzig, Saxony, Germany, 04103
    - Recruiting
    - Novartis Investigative Site
  - Neustadt in Sachsen, Saxony, Germany, 01844
    - Recruiting
    - Novartis Investigative Site
  - Plauen, Saxony, Germany, 08525
    - Recruiting
    - Novartis Investigative Site
  - Radebeul, Saxony, Germany, 01445
    - Recruiting
    - Novartis Investigative Site
  - Rodewisch, Saxony, Germany, 08228
    - Recruiting
    - Novartis Investigative Site
  - Scheibenberg, Saxony, Germany, 09481
    - Recruiting
    - Novartis Investigative Site
  - Schkeuditz, Saxony, Germany, 04435
    - Recruiting
    - Novartis Investigative Site
  - Zittau, Saxony, Germany, 02763
    - Recruiting
    - Novartis Investigative Site
- Saxony-Anhalt
  - Halle, Saxony-Anhalt, Germany, 06110
    - Recruiting
    - Novartis Investigative Site
  - Halle, Saxony-Anhalt, Germany, 06120
    - Recruiting
    - Novartis Investigative Site
  - Hansestadt Salzwedel, Saxony-Anhalt, Germany, 29410
    - Recruiting
    - Novartis Investigative Site
  - Magdeburg, Saxony-Anhalt, Germany, 39108
    - Recruiting
    - Novartis Investigative Site
  - Magdeburg, Saxony-Anhalt, Germany, 39130
    - Recruiting
    - Novartis Investigative Site
  - Stendal, Saxony-Anhalt, Germany, 39576
    - Recruiting
    - Novartis Investigative Site
- Schleswig-Holstein
  - Flensburg, Schleswig-Holstein, Germany, 24939
    - Recruiting
    - Novartis Investigative Site
  - Lübeck, Schleswig-Holstein, Germany, 23563
    - Recruiting
    - Novartis Investigative Site
  - Rendsburg, Schleswig-Holstein, Germany, 24768
    - Recruiting
    - Novartis Investigative Site
- State of Berlin
  - Berlin, State of Berlin, Germany, 13156
    - Recruiting
    - Novartis Investigative Site
- Thuringia
  - Jena, Thuringia, Germany, 07740
    - Recruiting
    - Novartis Investigative Site
  - Mühlhausen, Thuringia, Germany, 99974
    - Recruiting
    - Novartis Investigative Site
  - Nordhausen, Thuringia, Germany, 99734
    - Recruiting
    - Novartis Investigative Site
  - Saalfeld, Thuringia, Germany, 07318
    - Recruiting
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
abemaciclib abemaciclib + ET ± LHRH	Drug: 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	Drug: 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.
ribociclib ribociclib + AI ± LHRH	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants per Baseline parameters Time Frame: baseline	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	baseline
Reasons for treatment decision by treating physician Time Frame: baseline	Reason for treatment decision documented by the treating physician	baseline
Invasive disease-free survival (iDFS) (ribociclib cohort) Time Frame: 12 and 24 months	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).	12 and 24 months
Invasive breast cancer-free survival (iBCFS) (ribociclib cohort) Time Frame: 12, 24 and 36 months	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.	12, 24 and 36 months
Recurrence-free survival (RFS) (ribociclib cohort) Time Frame: 12, 24 and 36 months	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).	12, 24 and 36 months
Distant disease-free survival (DDFS) (ribociclib cohort) Time Frame: 12, 24 and 36 months	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).	12, 24 and 36 months
Incidence and severity of adverse events (ribociclib cohort) Time Frame: up to 36 months	Incidence and severity of adverse events	up to 36 months
Dose modification rates (ribociclib cohort) Time Frame: up to 36 months	Proportion of patients with dose modification and underlying cause	up to 36 months
Treatment interruption rates (ribociclib cohort) Time Frame: up to 36 months	Proportion of patients with treatment interruption and underlying cause	up to 36 months
Discontinuation rates (ribociclib cohort) Time Frame: up to 36 months	Proportion of patients who discontinued treatment and underlying cause	up to 36 months
Time to discontinuation (TTD) (ribociclib cohort) Time Frame: up to 36 months	Time from treatment start to permanent treatment discontinuation	up to 36 months
Quality of life by EORTC QLQ-C30 (ribociclib and abemaciclib cohorts) Time Frame: up to 39 months	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.	up to 39 months
Quality of life by EORTC QLQ-BR42 (ribociclib and abemaciclib cohorts) Time Frame: up to 39 months	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.	up to 39 months
Quality of life by HADS D (ribociclib and abemaciclib cohorts) Time Frame: up to 39 months	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.	up to 39 months
Participant compliance as assessed by a physician adherence rating (ribociclib cohort) Time Frame: up to 36 months	Participant compliance as assessed by a physician adherence rated as very good, good, moderate, or poor.	up to 36 months
Participant compliance as assessed by neutrophil count (ribociclib cohort) Time Frame: up to 36 months	Participant compliance as assessed by neutrophil count.	up to 36 months
Socio-economic status of participants measured by WPAI-GH (ribociclib and abemaciclib cohorts) Time Frame: up to 39 months	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).	up to 39 months
Number of participants per reason for treatment discontinuation (ribociclib and abemaciclib cohorts) Time Frame: up to 39 months	Reported reasons for treatment discontinuation	up to 39 months
Type of subsequent anti-neoplastic therapies (ribociclib and abemaciclib cohorts) Time Frame: up to 39 months	Type of subsequent anti-neoplastic therapies will be recorded	up to 39 months
Time to subsequent anti-neoplastic therapy (ribociclib and abemaciclib cohorts) Time Frame: up to 39 months	Time from study start to first subsequent anti-neoplastic therapy	up to 39 months
Participants' expectations regarding therapy, side effects and management (ribociclib and abemaciclib cohorts) Time Frame: baseline	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	baseline
Participants' treatment satisfaction (ribociclib and abemaciclib cohorts) Time Frame: up to 24 months	Treatment satisfaction assessed by a questionnaire containing 5 questions with each 5-7 ordinal answer categories with the same directionality on treatment satisfaction	up to 24 months
Patients' individual perception of risk of recurrence and treatment decision Time Frame: baseline	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	baseline
Participant compliance as assessed by the Medication Adherence Report Scale (MARS-D) (ribociclib and abemaciclib cohorts) Time Frame: up to 36 months	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.	up to 36 months
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) Time Frame: up to 36 months	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.	up to 36 months
Impact of digital health solutions applied in clinical routine on participant compliance assessed by MARS-D (ribociclib cohort) Time Frame: up to 36 months	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.	up to 36 months
Impact of an active participation of the participant in the treatment decision on subsequent participant compliance measured by MARS-D (ribociclib cohort) Time Frame: up to 36 months	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.	up to 36 months
Impact of participants' fear of cancer recurrence on participant compliance measured by MARS-D (ribociclib cohort) Time Frame: up to 36 months	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.	up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CLEE011O1DE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

G1 Therapeutics, Inc.

Terminated

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

Breast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast Neoplasms

United States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
Innocrin Pharmaceutical

Completed

CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448) (CLARITY-01)

Breast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the Breast

United States
Dana-Farber Cancer Institute
Incyte Corporation

Active, not recruiting

Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer

Inflammatory Breast Cancer (IBC)

United States
Providence Health & Services
Brooklyn ImmunoTherapeutics, LLC

Completed

Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)

Breast Neoplasm | Triple Negative Breast Cancer | Breast Neoplasm, Male

United States
Xijing Hospital

Active, not recruiting

Exemption of SLNB After Neoadjuvant Therapy for Triple-negative and Her2-positive Breast Cancer

Breast Cancer | Breast Cancer (Triple Negative Breast Cancer (TNBC))

China
Emory University
Eisai Inc.

Terminated

Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

Breast Cancer | Breast Neoplasms | Breast Tumors | Neoplasms, Breast | Cancer of the Breast | Tumors, Breast

United States
BerGenBio ASA
Merck Sharp & Dohme LLC

Terminated

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC

Triple Negative Breast Cancer | Inflammatory Breast Cancer Stage IV

Spain, United States, United Kingdom, Norway
CytomX Therapeutics

Completed

Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

Neoplasms | Breast Cancer | Breast Neoplasms | Breast Neoplasms, Triple-Negative | Breast Neoplasms, Hormone Receptor Positive/HER2 Negative

United States, Spain, Korea, Republic of
Seagen Inc.

Completed

A Safety Study of SGN-LIV1A in Breast Cancer Patients

Triple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast Neoplasms

United States
Beaumont Hospital

Recruiting

Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction (REBORN)

Robotic Surgery | Breast Reconstruction | DIEP Flap Breast Reconstruction | Breast Cancer, Breast Neoplasms

Ireland

Clinical Trials on ET mono ± LHRH

Menoufia University
Alexandria University

Completed

Ultrasound Guidance for Embryo Transfer

Infertility

Egypt
Universidad de Zaragoza
University of Valladolid

Completed

Pain Education and Therapeutic Exercise for Fibromyalgia

Fibromyalgia

Spain
Universidad Miguel Hernandez de Elche

Not yet recruiting

Effects of Percutaneous Electrical Stimulation in Patients With Chronic Supraspinatus Tendinopathy

Supraspinatus Tendinopathy

Spain
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)

Active, not recruiting

ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)

Chronic Conditions, Multiple

United States
Centre Hospitalier Universitaire, Amiens

Recruiting

MRI-Eye Tracking Pairing, a Tool for Assessing Social Cognition in Children With ASD (IRM-ET)

Functional Magnetic Resonance Imaging | ASD | Social Cognition | Eye Tracking | Joint Attention

France
University of Aarhus

Unknown

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Precocious Puberty

Denmark
Vyaire Medical
M.D. Anderson Cancer Center

Completed

SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation (iOXYGENATE)

Hypoxemia

United States
Institute of Hematology & Blood Diseases Hospital...
EdiGene Inc.; The Affiliated Hospital Of Guizhou Medical University; Zunyi Medical...

Completed

Safety and Efficacy Evaluation of ET-01 Transplantation in Subjects With Transfusion Dependent β-Thalassaemia

Transfusion Dependent Beta-Thalassaemia

China
Children's Hospital of Philadelphia
Anesthesia Patient Safety Foundation

Completed

The Videolaryngoscopy in Small Infants (VISI)

Surgery | Anesthesia, Endotracheal

United States, Australia
Faculty of Medicine, Sousse

Completed

Chronic Obstructive Pulmonary Disease (COPD)

COPD

Tunisia

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)

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Breast Neoplasms

Clinical Trials on ET mono ± LHRH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations