A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment (RIBANNA)

A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor/Fulvestrant, or With Endocrine Therapy or Chemotherapy as First Line Treatment

This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: First-line Ribociclib + endocrine therapy; Drug: First-line endocrine therapy; Drug: First-line chemtherapy

Detailed Description

This non-interventional study collects data from clinical practice capturing on effectiveness, safety and tolerability, duration of therapy, and quality of life of ribociclib in combination with an aromatase inhibitor/fulvestrant in daily routine and in line with the respective current German summary of product characteristics. In order to put these results into perspective, data is also collected on patients treated with endocrine therapy or chemotherapy for first line locally advanced or metastatic breast cancer. To gain insight into algorithms and outcome of sequential therapy, up to three lines of treatment are documented within this study. The information gathered and evaluated in this NIS is helping to answer open questions for the treatment of locally advanced/metastatic breast cancer and provides first insights into the treatment reality with ribociclib in this setting. This includes, but is not limited to, the questions on baseline demographics leading to a specific treatment decision, as well as efficacy and clinical routine related to treatment sequencing. In addition, data on the mutation status (including PIK3CA and BRCA1/2) is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing.

• Study Type: Observational
• Enrollment (Actual): 2610

Contacts and Locations

Study Locations

• Germany
  • Altötting, Germany, 84503
    • Novartis Investigative Site
  • Augsburg, Germany, 86179
    • Novartis Investigative Site
  • Augsburg, Germany, 86150
    • Novartis Investigative Site
  • Bad Liebenwerda, Germany, 04924
    • Novartis Investigative Site
  • Bamberg, Germany, 96049
    • Novartis Investigative Site
  • Bayreuth, Germany, 95445
    • Novartis Investigative Site
  • Berlin, Germany, 14169
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Berlin, Germany, 13581
    • Novartis Investigative Site
  • Berlin, Germany, 12487
    • Novartis Investigative Site
  • Berlin, Germany, 10715
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
  • Bonn, Germany, 53111
    • Novartis Investigative Site
  • Bonn, Germany, 53113
    • Novartis Investigative Site
  • Bottrop, Germany, 46236
    • Novartis Investigative Site
  • Brandenburg, Germany, 14770
    • Novartis Investigative Site
  • Bremen, Germany, 28205
    • Novartis Investigative Site
  • Bremerhaven, Germany, 27574
    • Novartis Investigative Site
  • Böblingen, Germany, 71032
    • Novartis Investigative Site
  • Celle, Germany, 29223
    • Novartis Investigative Site
  • Chemnitz, Germany, 09117
    • Novartis Investigative Site
  • Chemnitz, Germany, 09113
    • Novartis Investigative Site
  • Cologne, Germany, 50671
    • Novartis Investigative Site
  • Cologne, Germany, 50935
    • Novartis Investigative Site
  • Cologne, Germany, 51067
    • Novartis Investigative Site
  • Dessau, Germany, 06847
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Erfurt, Germany, 99084
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Esslingen am Neckar, Germany, 73730
    • Novartis Investigative Site
  • Eutin, Germany, 23701
    • Novartis Investigative Site
  • Friedberg, Germany, 86316
    • Novartis Investigative Site
  • Friedrichshafen, Germany, 88045
    • Novartis Investigative Site
  • Gera, Germany, 07548
    • Novartis Investigative Site
  • Goch, Germany, 47574
    • Novartis Investigative Site
  • Goslar, Germany, 38642
    • Novartis Investigative Site
  • Greifswald, Germany, 17475
    • Novartis Investigative Site
  • Gummersbach, Germany, 51643
    • Novartis Investigative Site
  • Göttingen, Germany, 37075
    • Novartis Investigative Site
  • Göttingen, Germany, 37073
    • Novartis Investigative Site
  • Halberstadt, Germany, 38820
    • Novartis Investigative Site
  • Hamburg, Germany, 20259
    • Novartis Investigative Site
  • Hamburg, Germany, 20357
    • Novartis Investigative Site
  • Hamburg, Germany, 22081
    • Novartis Investigative Site
  • Hamelin, Germany, 31785
    • Novartis Investigative Site
  • Hanau, Germany, 63450
    • Novartis Investigative Site
  • Hanover, Germany, 30625
    • Novartis Investigative Site
  • Hanover, Germany, 30161
    • Novartis Investigative Site
  • Hanover, Germany, 30177
    • Novartis Investigative Site
  • Hof, Germany, 95028
    • Novartis Investigative Site
  • Homburg, Germany, 66421
    • Novartis Investigative Site
  • Kaiserslautern, Germany, 67655
    • Novartis Investigative Site
  • Karlsruhe, Germany, 76133
    • Novartis Investigative Site
  • Karlsruhe, Germany, 76135
    • Novartis Investigative Site
  • Kassel, Germany, 34119
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Koblenz, Germany, 56068
    • Novartis Investigative Site
  • Kulmbach, Germany, 95326
    • Novartis Investigative Site
  • Leipzig, Germany, 04277
    • Novartis Investigative Site
  • Loerrach, Germany, 79539
    • Novartis Investigative Site
  • Lübeck, Germany, 23538
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Marburg, Germany, 35037
    • Novartis Investigative Site
  • Marktredwitz, Germany, 95615
    • Novartis Investigative Site
  • Memmingen, Germany, 87700
    • Novartis Investigative Site
  • Minden, Germany, 32429
    • Novartis Investigative Site
  • Moers, Germany, 47441
    • Novartis Investigative Site
  • Münster, Germany, 48145
    • Novartis Investigative Site
  • Naunhof, Germany, 04683
    • Novartis Investigative Site
  • Neuruppin, Germany, 16816
    • Novartis Investigative Site
  • Neuss, Germany, 41464
    • Novartis Investigative Site
  • Neuss, Germany, 41462
    • Novartis Investigative Site
  • Nuremberg, Germany, 90419
    • Novartis Investigative Site
  • Nuremberg, Germany, 90449
    • Novartis Investigative Site
  • Offenbach, Germany, 63069
    • Novartis Investigative Site
  • Offenburg, Germany, 77654
    • Novartis Investigative Site
  • Oldenburg, Germany, 26121
    • Novartis Investigative Site
  • Osnabrück, Germany, 49076
    • Novartis Investigative Site
  • Passau, Germany, 94036
    • Novartis Investigative Site
  • Potsdam, Germany, 14467
    • Novartis Investigative Site
  • Ravensburg, Germany, 88214
    • Novartis Investigative Site
  • Regensburg, Germany, 93053
    • Novartis Investigative Site
  • Rheine, Germany, 48431
    • Novartis Investigative Site
  • Rodgau, Germany, 63110
    • Novartis Investigative Site
  • Rosenheim, Germany, 83022
    • Novartis Investigative Site
  • Rostock, Germany, 18059
    • Novartis Investigative Site
  • Rüsselsheim am Main, Germany, 65428
    • Novartis Investigative Site
  • Saarbrücken, Germany, 66113
    • Novartis Investigative Site
  • Saarlouis, Germany, 66740
    • Novartis Investigative Site
  • Salzgitter, Germany, 38226
    • Novartis Investigative Site
  • Schkeuditz, Germany, 04435
    • Novartis Investigative Site
  • Schorndorf, Germany, 73614
    • Novartis Investigative Site
  • Schweinfurt, Germany, 97422
    • Novartis Investigative Site
  • Schwäbisch Hall, Germany, 74523
    • Novartis Investigative Site
  • Soest, Germany, 59494
    • Novartis Investigative Site
  • Stade, Germany, 21680
    • Novartis Investigative Site
  • Stendal, Germany, 39576
    • Novartis Investigative Site
  • Stolberg, Germany, 52222
    • Novartis Investigative Site
  • Stuttgart, Germany, 70174
    • Novartis Investigative Site
  • Stuttgart, Germany, 70199
    • Novartis Investigative Site
  • Suhl, Germany, 98527
    • Novartis Investigative Site
  • Torgau, Germany, 04860
    • Novartis Investigative Site
  • Trier, Germany, 54290
    • Novartis Investigative Site
  • Tübingen, Germany, 72076
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Novartis Investigative Site
  • Ulm, Germany, 89073
    • Novartis Investigative Site
  • Vechta, Germany, 49377
    • Novartis Investigative Site
  • Völklingen, Germany, 66333
    • Novartis Investigative Site
  • Weiden, Germany, 92637
    • Novartis Investigative Site
  • Weinheim, Germany, 69469
    • Novartis Investigative Site
  • Wetzlar, Germany, 35578
    • Novartis Investigative Site
  • Wiesbaden, Germany, 65189
    • Novartis Investigative Site
  • Wilhelmshaven, Germany, 26389
    • Novartis Investigative Site
  • Wolfsburg, Germany, 38440
    • Novartis Investigative Site
  • Worms, Germany, 67550
    • Novartis Investigative Site
  • Würselen, Germany, 52146
    • Novartis Investigative Site
  • Würzburg, Germany, 97080
    • Novartis Investigative Site
  • Baden-Wurttemberg
    • Baden-Baden, Baden-Wurttemberg, Germany, 76532
      • Novartis Investigative Site
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Novartis Investigative Site
    • Freudenstadt, Baden-Wurttemberg, Germany, 72250
      • Novartis Investigative Site
    • Heidenheim, Baden-Wurttemberg, Germany, 89522
      • Novartis Investigative Site
    • Karlsruhe, Baden-Wurttemberg, Germany, 76199
      • Novartis Investigative Site
    • Mannheim, Baden-Wurttemberg, Germany, 68161
      • Novartis Investigative Site
    • Mannheim, Baden-Wurttemberg, Germany, 68165
      • Novartis Investigative Site
    • Mutlangen, Baden-Wurttemberg, Germany, 73557
      • Novartis Investigative Site
    • Nürtingen, Baden-Wurttemberg, Germany, 72622
      • Novartis Investigative Site
    • Ostfildern, Baden-Wurttemberg, Germany, 73760
      • Novartis Investigative Site
    • Pforzheim, Baden-Wurttemberg, Germany, 75175
      • Novartis Investigative Site
    • Reutlingen, Baden-Wurttemberg, Germany, 72764
      • Novartis Investigative Site
    • Rottweil, Baden-Wurttemberg, Germany, 78628
      • Novartis Investigative Site
    • Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523
      • Novartis Investigative Site
    • Sigmaringen, Baden-Wurttemberg, Germany, 72488
      • Novartis Investigative Site
    • Winnenden, Baden-Wurttemberg, Germany, 71364
      • Novartis Investigative Site
  • Bavaria
    • Altötting, Bavaria, Germany, 84503
      • Novartis Investigative Site
    • Amberg, Bavaria, Germany, 92224
      • Novartis Investigative Site
    • Ansbach, Bavaria, Germany, 91522
      • Novartis Investigative Site
    • Aschaffenburg, Bavaria, Germany, 63739
      • Novartis Investigative Site
    • Augsburg, Bavaria, Germany, 86152
      • Novartis Investigative Site
    • Bamberg, Bavaria, Germany, 96052
      • Novartis Investigative Site
    • Bayreuth, Bavaria, Germany, 95445
      • Novartis Investigative Site
    • Donauwörth, Bavaria, Germany, 86609
      • Novartis Investigative Site
    • Ebersberg, Bavaria, Germany, 85560
      • Novartis Investigative Site
    • Eggenfelden, Bavaria, Germany, 84307
      • Novartis Investigative Site
    • Kempten (Allgäu), Bavaria, Germany, 87439
      • Novartis Investigative Site
    • Kronach, Bavaria, Germany, 96317
      • Novartis Investigative Site
    • Krumbach, Bavaria, Germany, 86381
      • Novartis Investigative Site
    • Landshut, Bavaria, Germany, 84036
      • Novartis Investigative Site
    • Munich, Bavaria, Germany, 81241
      • Novartis Investigative Site
    • Munich, Bavaria, Germany, 81925
      • Novartis Investigative Site
    • Munich, Bavaria, Germany, 80639
      • Novartis Investigative Site
    • Nuremberg, Bavaria, Germany, 90409
      • Novartis Investigative Site
    • Regensburg, Bavaria, Germany, 93053
      • Novartis Investigative Site
    • Straubing, Bavaria, Germany, 94315
      • Novartis Investigative Site
    • Würzburg, Bavaria, Germany, 97080
      • Novartis Investigative Site
    • Würzburg, Bavaria, Germany, 97070
      • Novartis Investigative Site
  • Beden Wuerttenberg
    • Mannheim, Beden Wuerttenberg, Germany, 68167
      • Novartis Investigative Site
  • Brandenburg
    • Brandenburg, Brandenburg, Germany, 14770
      • Novartis Investigative Site
    • Cottbus, Brandenburg, Germany, 03048
      • Novartis Investigative Site
    • Doberlug-Kirchhain, Brandenburg, Germany, 03253
      • Novartis Investigative Site
    • Fürstenwalde, Brandenburg, Germany, 15517
      • Novartis Investigative Site
    • Ludwigsfelde, Brandenburg, Germany, 14974
      • Novartis Investigative Site
    • Spremberg, Brandenburg, Germany, 03130
      • Novartis Investigative Site
  • City state Bremen
    • Bremen, City state Bremen, Germany, 28209
      • Novartis Investigative Site
    • Bremen, City state Bremen, Germany, 28239
      • Novartis Investigative Site
    • Bremerhaven, City state Bremen, Germany, 27576
      • Novartis Investigative Site
  • Germany
    • Schwerte, Germany, Germany, 58239
      • Novartis Investigative Site
    • Wiesbaden, Germany, Germany, 65191
      • Novartis Investigative Site
  • Hamburg
    • Hamburg, Hamburg, Germany, 22087
      • Novartis Investigative Site
    • Hamburg, Hamburg, Germany, 22291
      • Novartis Investigative Site
    • Hamburg, Hamburg, Germany, 22457
      • Novartis Investigative Site
  • Hesse
    • Bad Homburg, Hesse, Germany, 61352
      • Novartis Investigative Site
    • Bad Nauheim, Hesse, Germany, 61231
      • Novartis Investigative Site
    • Darmstadt, Hesse, Germany, 64283
      • Novartis Investigative Site
    • Erbach im Odenwald, Hesse, Germany, 64711
      • Novartis Investigative Site
    • Frankfurt am Main, Hesse, Germany, 60431
      • Novartis Investigative Site
    • Frankfurt am Main, Hesse, Germany, 60398
      • Novartis Investigative Site
    • Frankfurt am Main, Hesse, Germany, 65929
      • Novartis Investigative Site
    • Langen, Hesse, Germany, 63225
      • Novartis Investigative Site
    • Lich, Hesse, Germany, 35423
      • Novartis Investigative Site
    • Marburg, Hesse, Germany, 35043
      • Novartis Investigative Site
  • Lower Saxony
    • Braunschweig, Lower Saxony, Germany, 38100
      • Novartis Investigative Site
    • Buchholz, Lower Saxony, Germany, 21244
      • Novartis Investigative Site
    • Damme, Lower Saxony, Germany, 49401
      • Novartis Investigative Site
    • Georgsmarienhütte, Lower Saxony, Germany, 49124
      • Novartis Investigative Site
    • Hamelin, Lower Saxony, Germany, 31785
      • Novartis Investigative Site
    • Hanover, Lower Saxony, Germany, 30171
      • Novartis Investigative Site
    • Hildesheim, Lower Saxony, Germany, 31134
      • Novartis Investigative Site
    • Ilsede, Lower Saxony, Germany, 31241
      • Novartis Investigative Site
    • Lingen Ems, Lower Saxony, Germany, 49808
      • Novartis Investigative Site
    • Osnabrück, Lower Saxony, Germany, 49076
      • Novartis Investigative Site
    • Rotenburg (Wümme), Lower Saxony, Germany, 27356
      • Novartis Investigative Site
    • Twistringen, Lower Saxony, Germany, 27239
      • Novartis Investigative Site
    • Westerstede, Lower Saxony, Germany, 26655
      • Novartis Investigative Site
    • Wolfenbüttel, Lower Saxony, Germany, 38304
      • Novartis Investigative Site
  • Mecklenburg-Vorpommern
    • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
      • Novartis Investigative Site
    • Rostock, Mecklenburg-Vorpommern, Germany, 18057
      • Novartis Investigative Site
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19059
      • Novartis Investigative Site
    • Stralsund, Mecklenburg-Vorpommern, Germany, 18435
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Arnsberg, North Rhine-Westphalia, Germany, 59759
      • Novartis Investigative Site
    • Bergisch Gladbach, North Rhine-Westphalia, Germany, 51465
      • Novartis Investigative Site
    • Bielefeld, North Rhine-Westphalia, Germany, 33611
      • Novartis Investigative Site
    • Bielefeld, North Rhine-Westphalia, Germany, 33615
      • Novartis Investigative Site
    • Bochum, North Rhine-Westphalia, Germany, 44787
      • Novartis Investigative Site
    • Bonn, North Rhine-Westphalia, Germany, 53113
      • Novartis Investigative Site
    • Bonn, North Rhine-Westphalia, Germany, 53177
      • Novartis Investigative Site
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Novartis Investigative Site
    • Cologne, North Rhine-Westphalia, Germany, 50179
      • Novartis Investigative Site
    • Dortmund, North Rhine-Westphalia, Germany, 44309
      • Novartis Investigative Site
    • Dortmund, North Rhine-Westphalia, Germany, 44137
      • Novartis Investigative Site
    • Düsseldorf, North Rhine-Westphalia, Germany, 40325
      • Novartis Investigative Site
    • Düsseldorf, North Rhine-Westphalia, Germany, 40625
      • Novartis Investigative Site
    • Gelsenkirchen, North Rhine-Westphalia, Germany, 45879
      • Novartis Investigative Site
    • Hagen, North Rhine-Westphalia, Germany, 58089
      • Novartis Investigative Site
    • Herdecke, North Rhine-Westphalia, Germany, 58313
      • Novartis Investigative Site
    • Herne, North Rhine-Westphalia, Germany, 44649
      • Novartis Investigative Site
    • Hilden, North Rhine-Westphalia, Germany, 40724
      • Novartis Investigative Site
    • Krefeld, North Rhine-Westphalia, Germany, 47805
      • Novartis Investigative Site
    • Lemgo, North Rhine-Westphalia, Germany, 32657
      • Novartis Investigative Site
    • Mönchengladbach, North Rhine-Westphalia, Germany, 41061
      • Novartis Investigative Site
    • Olpe, North Rhine-Westphalia, Germany, 57462
      • Novartis Investigative Site
    • Paderborn, North Rhine-Westphalia, Germany, 33098
      • Novartis Investigative Site
    • Remscheid, North Rhine-Westphalia, Germany, 42853
      • Novartis Investigative Site
    • Remscheid, North Rhine-Westphalia, Germany, 42859
      • Novartis Investigative Site
    • Siegen, North Rhine-Westphalia, Germany, 57072
      • Novartis Investigative Site
    • Troisdorf, North Rhine-Westphalia, Germany, 53840
      • Novartis Investigative Site
    • Velbert, North Rhine-Westphalia, Germany, 42551
      • Novartis Investigative Site
    • Wesel, North Rhine-Westphalia, Germany, 46483
      • Novartis Investigative Site
    • Wesel, North Rhine-Westphalia, Germany, 46485
      • Novartis Investigative Site
    • Witten, North Rhine-Westphalia, Germany, 58455
      • Novartis Investigative Site
  • Rhineland-Palatinate
    • Mayen, Rhineland-Palatinate, Germany, 56727
      • Novartis Investigative Site
    • Neustadt an der Weinstraße, Rhineland-Palatinate, Germany, 67434
      • Novartis Investigative Site
    • Simmern, Rhineland-Palatinate, Germany, 55469
      • Novartis Investigative Site
  • Saarland
    • Lebach, Saarland, Germany, 66822
      • Novartis Investigative Site
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Novartis Investigative Site
    • Dresden, Saxony, Germany, 01127
      • Novartis Investigative Site
    • Leipzig, Saxony, Germany, 04103
      • Novartis Investigative Site
    • Leipzig, Saxony, Germany, 04129
      • Novartis Investigative Site
    • Lohsa-Weisskollm, Saxony, Germany, 02999
      • Novartis Investigative Site
    • Neustadt in Sachsen, Saxony, Germany, 01844
      • Novartis Investigative Site
    • Pirna, Saxony, Germany, 01796
      • Novartis Investigative Site
    • Plauen, Saxony, Germany, 08525
      • Novartis Investigative Site
    • Rodewisch, Saxony, Germany, 08228
      • Novartis Investigative Site
    • Scheibenberg, Saxony, Germany, 09481
      • Novartis Investigative Site
    • Schkeuditz, Saxony, Germany, 04435
      • Novartis Investigative Site
    • Zittau, Saxony, Germany, 02763
      • Novartis Investigative Site
    • Zxickau, Saxony, Germany, 08060
      • Novartis Investigative Site
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06110
      • Novartis Investigative Site
    • Magdeburg, Saxony-Anhalt, Germany, 39108
      • Novartis Investigative Site
    • Magdeburg, Saxony-Anhalt, Germany, 39130
      • Novartis Investigative Site
    • Quedlinburg, Saxony-Anhalt, Germany, 06484
      • Novartis Investigative Site
  • Schleswig-Holstein
    • Flensburg, Schleswig-Holstein, Germany, 24939
      • Novartis Investigative Site
    • Lübeck, Schleswig-Holstein, Germany, 23563
      • Novartis Investigative Site
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10117
      • Novartis Investigative Site
    • Berlin, State of Berlin, Germany, 10317
      • Novartis Investigative Site
    • Berlin, State of Berlin, Germany, 13187
      • Novartis Investigative Site
    • Berlin, State of Berlin, Germany, 14197
      • Novartis Investigative Site
  • Thuringia
    • Apolda, Thuringia, Germany, 99510
      • Novartis Investigative Site
    • Eisenach, Thuringia, Germany, 99817
      • Novartis Investigative Site
    • Erfurt, Thuringia, Germany, 99084
      • Novartis Investigative Site
    • Jena, Thuringia, Germany, 07740
      • Novartis Investigative Site
    • Meiningen, Thuringia, Germany, 98617
      • Novartis Investigative Site
    • Mühlhausen, Thuringia, Germany, 99974
      • Novartis Investigative Site
    • Nordhausen, Thuringia, Germany, 99734
      • Novartis Investigative Site
    • Suhl, Thuringia, Germany, 98527
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult females with HR+/HER2- locally advanced/metastatic breast cancer (progressed following prior therapy or de novo). Hereby locally advanced is defined by the following criteria (at least one must apply): tumor size > 5 cm (T3), skin or chest wall infiltration (T4a, T4b), inflammatory breast cancer (T4c), fixed axilla-located lymph node conglomerate or intraclavicular lymph node metastasis (cN3; German S3 guideline for early detection, diagnosis, therapy and follow-up care of breast cancer; Version 4.1.2018). Patients are classified as therapy naïve for locally advanced/metastatic disease if they have not yet received a systemic therapy in the palliative setting. Patients with locally advanced breast cancer who have received therapy-(lines) in the adjuvant/curative setting are eligible after progression to e.g. a metastatic breast cancer. All patients who already received a palliative therapy for locally advanced/metastatic breast cancer are excluded from study participation.

Description

Inclusion Criteria:

• Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status
• No prior systemic treatment for locally advanced/metastatic disease in the palliative setting
• The treating physician has made the decision to treat the patient
• with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or
• endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or
• chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab)
• Written informed consent of the patient
• Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study
• Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics")
• Patient is ≥18 years

Exclusion Criteria:

• Patients unable to provide written informed consent
• Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician
• The patient is currently under active treatment in an investigational study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First-line Ribociclib + endocrine therapy; Ribociclib + letrozole, or Ribociclib + anastrozole, or Ribociclib + exemestane, or Ribociclib + fulvestrant	Drug: First-line Ribociclib + endocrine therapy; Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
First-line endocrine therapy; As of physicians choice	Drug: First-line endocrine therapy; As of physicians choice
First-line chemotherapy; As of physicians choice	Drug: First-line chemtherapy; As of physicians choice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival was defined as first intake of study medication in current-line therapy up to first documented progress or death from any cause in this treatment line. If a patient had not had an event, progression-free survival was censored at the end of the respective therapy line.	Up to 88 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequential progression-free survival (PFS_S)	Sequential progression-free survival up to second-line therapy was defined as time between first intake of study medication in first-line therapy up to progress or death after second-line therapy. Sequential progression-free survival up to third-line therapy was defined as time between first intake of study medication in first-line therapy up to progress or death after third-line therapy. Sequential progression-free survival for all further therapy lines were analyzed according to the definitions above.	Up to 88 months
Time to treatment failure (TTF)	Time to treatment failure (TTF) from current-line therapy was defined as time between first intake of study medication in current-line therapy up to therapy discontinuation because of progress, adverse events leading to discontinuation or death.	Up to 88 months
Time to first chemotherapy	Time to first chemotherapy was defined as time between first intake of study medication in first-line therapy up to first application of chemotherapy for patients enrolled in 1st line option ribociclib + AI/FU or endocrine therapy.	Up to 88 months
Time to next treatment / therapy (TTNT) after 1st line treatment	Time to next treatment / therapy (TTNT) was defined as time between first intake of study medication in first-line therapy up to first intake of medication in the next therapy line.	Up to 88 months
Overall survival (OS)	Overall survival (OS) was defined as time between first intake of study medication in first-line therapy up to death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.	Up to 88 months
Dose reduction	Dose reduction rates and reasons	Up to 88 months
Dose interruption	Dose interruption rates and reasons	Up to 88 months
Discontinuations	Discontinuations rates and reasons	Up to 88 months
Adherence - MMAS-8 questionnaire	Patient adherence for ribociclib was assessed using the MMAS-8 questionnaire. This questionnaire was only send to patients enrolled in the first-line option ribociclib + AI/FU. The score was analyzed using descriptive statistics and adherence categories low, medium and high were displayed by visit. Questionnaires were only included if all questionnaire items were answered. The total scale has a range of 0 to 8.0 where: Low Adherence (< 6); Medium Adherence (6 to <8); High Adherence (= 8)	Up to 87 weeks
Number of participants with mutations	Number of participants with mutations will be collected	Up to 88 months
Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30	Quality of life during documented therapy lines was assessed using the EORTC QLQ-C30. Scale and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	Up to 88 months
Quality of life for specific cohorts and treatment lines - HADS-D	Quality of life during documented therapy lines was assessed using the HADS-D. Scale ranges between 0 and 21, a high score means a high level of anxiety or depression.	Up to 88 months
Quality of life for specific cohorts and treatment lines - EORTC QLQ-BR23	Quality of life during documented therapy lines was assessed using the EORTC QLQ-BR23. Scale and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	Up to 88 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Decker T, Brucker C, Engel A, Fasching PA, Gohler T, Jackisch C, Janssen J, Kohler A, Ludtke-Heckenkamp K, Luftner D, Marme F, van Mackelenbergh M, Rautenberg B, Schmidt M, Weide R, Wimberger P, Kisseleff E, Pfister C, Roos C, Wilhelm N, Wockel A. Conditional progression-free survival in patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated with first-line ribociclib and endocrine therapy: real-world data from the RIBANNA study. ESMO Open. 2025 Jun;10(6):105105. doi: 10.1016/j.esmoop.2025.105105. Epub 2025 May 16.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; NIS; Ribociclib; Metastatic Breast Cancer; HR+; HER2-; Real World Evidence
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011ADE03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO