AzTrials
AzTrials

Breast CancerRIBANNANCT06311383

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

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 265 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
First-line Ribociclib + endocrine therapy, First-line endocrine therapy and First-line chemtherapy
How many people
2,610 participants
Where
265 sitesGermany
Study dates
9 Oct 2017to 10 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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

Trial locations and contacts

265 sites in 1 country.

265 sites in 1 country

Germany265 sites

  • Novartis Investigative Site

    Altötting, Bavaria, 84503

  • Novartis Investigative Site

    Altötting, 84503

  • Novartis Investigative Site

    Amberg, Bavaria, 92224

  • Novartis Investigative Site

    Ansbach, Bavaria, 91522

  • Novartis Investigative Site

    Apolda, Thuringia, 99510

  • Novartis Investigative Site

    Arnsberg, North Rhine-Westphalia, 59759

  • Novartis Investigative Site

    Aschaffenburg, Bavaria, 63739

  • Novartis Investigative Site

    Augsburg, Bavaria, 86152

  • Novartis Investigative Site

    Augsburg, 86150

  • Novartis Investigative Site

    Augsburg, 86179

  • Novartis Investigative Site

    Bad Homburg, Hesse, 61352

  • Novartis Investigative Site

    Bad Liebenwerda, 04924

  • Novartis Investigative Site

    Bad Nauheim, Hesse, 61231

  • Novartis Investigative Site

    Baden-Baden, Baden-Wurttemberg, 76532

  • Novartis Investigative Site

    Bamberg, Bavaria, 96052

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Bayreuth, Bavaria, 95445

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Bergisch Gladbach, North Rhine-Westphalia, 51465

  • Novartis Investigative Site

    Berlin, State of Berlin, 10117

  • Novartis Investigative Site

    Berlin, State of Berlin, 10317

  • Novartis Investigative Site

    Berlin, State of Berlin, 13187

  • Novartis Investigative Site

    Berlin, State of Berlin, 14197

  • Novartis Investigative Site

    Berlin, 10715

  • Novartis Investigative Site

    Berlin, 12487

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 13581

  • Novartis Investigative Site

    Berlin, 14169

  • Novartis Investigative Site

    Bielefeld, North Rhine-Westphalia, 33611

  • Novartis Investigative Site

    Bielefeld, North Rhine-Westphalia, 33615

  • Novartis Investigative Site

    Böblingen, 71032

  • Novartis Investigative Site

    Bochum, North Rhine-Westphalia, 44787

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53113

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53177

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Bonn, 53113

  • Novartis Investigative Site

    Bottrop, 46236

  • Novartis Investigative Site

    Brandenburg, 14770

  • Novartis Investigative Site

    Brandenburg an der Havel, Brandenburg, 14770

  • Novartis Investigative Site

    Braunschweig, Lower Saxony, 38100

  • Novartis Investigative Site

    Bremen, Free Hanseatic City of Bremen, 28209

  • Novartis Investigative Site

    Bremen, Free Hanseatic City of Bremen, 28239

  • Novartis Investigative Site

    Bremen, 28205

  • Novartis Investigative Site

    Bremerhaven, Free Hanseatic City of Bremen, 27576

  • Novartis Investigative Site

    Bremerhaven, 27574

  • Novartis Investigative Site

    Buchholz, Lower Saxony, 21244

  • Novartis Investigative Site

    Celle, 29223

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50179

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Cologne, 50671

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Cologne, 51067

  • Novartis Investigative Site

    Cottbus, Brandenburg, 03048

  • Novartis Investigative Site

    Damme, Lower Saxony, 49401

  • Novartis Investigative Site

    Darmstadt, Hesse, 64283

  • Novartis Investigative Site

    Dessau, 06847

  • Novartis Investigative Site

    Doberlug-Kirchhain, Brandenburg, 03253

  • Novartis Investigative Site

    Donauwörth, Bavaria, 86609

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia, 44137

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia, 44309

  • Novartis Investigative Site

    Dresden, Saxony, 01127

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40325

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40625

  • Novartis Investigative Site

    Ebersberg, Bavaria, 85560

  • Novartis Investigative Site

    Eggenfelden, Bavaria, 84307

  • Novartis Investigative Site

    Eisenach, Thuringia, 99817

  • Novartis Investigative Site

    Erbach im Odenwald, Hesse, 64711

  • Novartis Investigative Site

    Erfurt, Thuringia, 99084

  • Novartis Investigative Site

    Erfurt, 99084

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Esslingen am Neckar, 73730

  • Novartis Investigative Site

    Eutin, 23701

  • Novartis Investigative Site

    Flensburg, Schleswig-Holstein, 24939

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60398

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60431

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 65929

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Freudenstadt, Baden-Wurttemberg, 72250

  • Novartis Investigative Site

    Friedberg, 86316

  • Novartis Investigative Site

    Friedrichshafen, 88045

  • Novartis Investigative Site

    Fürstenwalde, Brandenburg, 15517

  • Novartis Investigative Site

    Gelsenkirchen, North Rhine-Westphalia, 45879

  • Novartis Investigative Site

    Georgsmarienhütte, Lower Saxony, 49124

  • Novartis Investigative Site

    Gera, 07548

  • Novartis Investigative Site

    Goch, 47574

  • Novartis Investigative Site

    Goslar, 38642

  • Novartis Investigative Site

    Göttingen, 37073

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Gummersbach, 51643

  • Novartis Investigative Site

    Hagen, North Rhine-Westphalia, 58089

  • Novartis Investigative Site

    Halberstadt, 38820

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06110

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg, 22087

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg, 22291

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg, 22457

  • Novartis Investigative Site

    Hamburg, 20259

  • Novartis Investigative Site

    Hamburg, 20357

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hamelin, Lower Saxony, 31785

  • Novartis Investigative Site

    Hamelin, 31785

  • Novartis Investigative Site

    Hanau, 63450

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30171

  • Novartis Investigative Site

    Hanover, 30161

  • Novartis Investigative Site

    Hanover, 30177

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidenheim, Baden-Wurttemberg, 89522

  • Novartis Investigative Site

    Herdecke, North Rhine-Westphalia, 58313

  • Novartis Investigative Site

    Herne, North Rhine-Westphalia, 44649

  • Novartis Investigative Site

    Hilden, North Rhine-Westphalia, 40724

  • Novartis Investigative Site

    Hildesheim, Lower Saxony, 31134

  • Novartis Investigative Site

    Hof, 95028

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Ilsede, Lower Saxony, 31241

  • Novartis Investigative Site

    Jena, Thuringia, 07740

  • Novartis Investigative Site

    Kaiserslautern, 67655

  • Novartis Investigative Site

    Karlsruhe, Baden-Wurttemberg, 76199

  • Novartis Investigative Site

    Karlsruhe, 76133

  • Novartis Investigative Site

    Karlsruhe, 76135

  • Novartis Investigative Site

    Kassel, 34119

  • Novartis Investigative Site

    Kempten (Allgäu), Bavaria, 87439

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Koblenz, 56068

  • Novartis Investigative Site

    Krefeld, North Rhine-Westphalia, 47805

  • Novartis Investigative Site

    Kronach, Bavaria, 96317

  • Novartis Investigative Site

    Krumbach, Bavaria, 86381

  • Novartis Investigative Site

    Kulmbach, 95326

  • Novartis Investigative Site

    Landshut, Bavaria, 84036

  • Novartis Investigative Site

    Langen, Hesse, 63225

  • Novartis Investigative Site

    Lebach, Saarland, 66822

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Leipzig, Saxony, 04129

  • Novartis Investigative Site

    Leipzig, 04277

  • Novartis Investigative Site

    Lemgo, North Rhine-Westphalia, 32657

  • Novartis Investigative Site

    Lich, Hesse, 35423

  • Novartis Investigative Site

    Lingen, Lower Saxony, 49808

  • Novartis Investigative Site

    Loerrach, 79539

  • Novartis Investigative Site

    Lohsa-Weisskollm, Saxony, 02999

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23563

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Ludwigsfelde, Brandenburg, 14974

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39108

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39130

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68161

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68165

  • Novartis Investigative Site

    Mannheim, Beden Wuerttenberg, 68167

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Marburg, 35037

  • Novartis Investigative Site

    Marktredwitz, 95615

  • Novartis Investigative Site

    Mayen, Rhineland-Palatinate, 56727

  • Novartis Investigative Site

    Meiningen, Thuringia, 98617

  • Novartis Investigative Site

    Memmingen, 87700

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    Moers, 47441

  • Novartis Investigative Site

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Novartis Investigative Site

    Mühlhausen, Thuringia, 99974

  • Novartis Investigative Site

    Munich, Bavaria, 80639

  • Novartis Investigative Site

    Munich, Bavaria, 81241

  • Novartis Investigative Site

    Munich, Bavaria, 81925

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Mutlangen, Baden-Wurttemberg, 73557

  • Novartis Investigative Site

    Naunhof, 04683

  • Novartis Investigative Site

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

  • Novartis Investigative Site

    Neuruppin, 16816

  • Novartis Investigative Site

    Neuss, 41462

  • Novartis Investigative Site

    Neuss, 41464

  • Novartis Investigative Site

    Neustadt an der Weinstraße, Rhineland-Palatinate, 67434

  • Novartis Investigative Site

    Neustadt in Sachsen, Saxony, 01844

  • Novartis Investigative Site

    Nordhausen, Thuringia, 99734

  • Novartis Investigative Site

    Nuremberg, Bavaria, 90409

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Nuremberg, 90449

  • Novartis Investigative Site

    Nürtingen, Baden-Wurttemberg, 72622

  • Novartis Investigative Site

    Offenbach, 63069

  • Novartis Investigative Site

    Offenburg, 77654

  • Novartis Investigative Site

    Oldenburg, 26121

  • Novartis Investigative Site

    Olpe, North Rhine-Westphalia, 57462

  • Novartis Investigative Site

    Osnabrück, Lower Saxony, 49076

  • Novartis Investigative Site

    Osnabrück, 49076

  • Novartis Investigative Site

    Ostfildern, Baden-Wurttemberg, 73760

  • Novartis Investigative Site

    Paderborn, North Rhine-Westphalia, 33098

  • Novartis Investigative Site

    Passau, 94036

  • Novartis Investigative Site

    Pforzheim, Baden-Wurttemberg, 75175

  • Novartis Investigative Site

    Pirna, Saxony, 01796

  • Novartis Investigative Site

    Plauen, Saxony, 08525

  • Novartis Investigative Site

    Potsdam, 14467

  • Novartis Investigative Site

    Quedlinburg, Saxony-Anhalt, 06484

  • Novartis Investigative Site

    Ravensburg, 88214

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

  • Novartis Investigative Site

    Regensburg, 93053

  • Novartis Investigative Site

    Remscheid, North Rhine-Westphalia, 42853

  • Novartis Investigative Site

    Remscheid, North Rhine-Westphalia, 42859

  • Novartis Investigative Site

    Reutlingen, Baden-Wurttemberg, 72764

  • Novartis Investigative Site

    Rheine, 48431

  • Novartis Investigative Site

    Rodewisch, Saxony, 08228

  • Novartis Investigative Site

    Rodgau, 63110

  • Novartis Investigative Site

    Rosenheim, 83022

  • Novartis Investigative Site

    Rostock, Mecklenburg-Vorpommern, 18057

  • Novartis Investigative Site

    Rostock, 18059

  • Novartis Investigative Site

    Rotenburg (Wümme), Lower Saxony, 27356

  • Novartis Investigative Site

    Rottweil, Baden-Wurttemberg, 78628

  • Novartis Investigative Site

    Rüsselsheim am Main, 65428

  • Novartis Investigative Site

    Saarbrücken, 66113

  • Novartis Investigative Site

    Saarlouis, 66740

  • Novartis Investigative Site

    Salzgitter, 38226

  • Novartis Investigative Site

    Scheibenberg, Saxony, 09481

  • Novartis Investigative Site

    Schkeuditz, Saxony, 04435

  • Novartis Investigative Site

    Schkeuditz, 04435

  • Novartis Investigative Site

    Schorndorf, 73614

  • Novartis Investigative Site

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • Novartis Investigative Site

    Schwäbisch Hall, 74523

  • Novartis Investigative Site

    Schweinfurt, 97422

  • Novartis Investigative Site

    Schwerin, Mecklenburg-Vorpommern, 19059

  • Novartis Investigative Site

    Schwerte, Germany, 58239

  • Novartis Investigative Site

    Siegen, North Rhine-Westphalia, 57072

  • Novartis Investigative Site

    Sigmaringen, Baden-Wurttemberg, 72488

  • Novartis Investigative Site

    Simmern, Rhineland-Palatinate, 55469

  • Novartis Investigative Site

    Soest, 59494

  • Novartis Investigative Site

    Spremberg, Brandenburg, 03130

  • Novartis Investigative Site

    Stade, 21680

  • Novartis Investigative Site

    Stendal, 39576

  • Novartis Investigative Site

    Stolberg, 52222

  • Novartis Investigative Site

    Stralsund, Mecklenburg-Vorpommern, 18435

  • Novartis Investigative Site

    Straubing, Bavaria, 94315

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Stuttgart, 70199

  • Novartis Investigative Site

    Suhl, Thuringia, 98527

  • Novartis Investigative Site

    Suhl, 98527

  • Novartis Investigative Site

    Torgau, 04860

  • Novartis Investigative Site

    Trier, 54290

  • Novartis Investigative Site

    Troisdorf, North Rhine-Westphalia, 53840

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Twistringen, Lower Saxony, 27239

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Vechta, 49377

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551

  • Novartis Investigative Site

    Völklingen, 66333

  • Novartis Investigative Site

    Weiden, 92637

  • Novartis Investigative Site

    Weinheim, 69469

  • Novartis Investigative Site

    Wesel, North Rhine-Westphalia, 46483

  • Novartis Investigative Site

    Wesel, North Rhine-Westphalia, 46485

  • Novartis Investigative Site

    Westerstede, Lower Saxony, 26655

  • Novartis Investigative Site

    Wetzlar, 35578

  • Novartis Investigative Site

    Wiesbaden, Germany, 65191

  • Novartis Investigative Site

    Wiesbaden, 65189

  • Novartis Investigative Site

    Wilhelmshaven, 26389

  • Novartis Investigative Site

    Winnenden, Baden-Wurttemberg, 71364

  • Novartis Investigative Site

    Witten, North Rhine-Westphalia, 58455

  • Novartis Investigative Site

    Wolfenbüttel, Lower Saxony, 38304

  • Novartis Investigative Site

    Wolfsburg, 38440

  • Novartis Investigative Site

    Worms, 67550

  • Novartis Investigative Site

    Würselen, 52146

  • Novartis Investigative Site

    Würzburg, Bavaria, 97070

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

  • Novartis Investigative Site

    Würzburg, 97080

  • Novartis Investigative Site

    Zittau, Saxony, 02763

  • Novartis Investigative Site

    Zxickau, Saxony, 08060

Other trials in Germany

About this study

Official title: 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

Read the 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.

Conditions
Breast Cancer
Being tested
First-line Ribociclib + endocrine therapy, First-line endocrine therapy, First-line chemtherapy
Keywords
Breast Cancer, NIS, Ribociclib, Metastatic Breast Cancer, HR+, HER2-, Real World Evidence
Medical subject headings
Breast Neoplasms

What participants receive

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

  • First-line Ribociclib + endocrine therapyDrug

    Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant

  • First-line endocrine therapyDrug

    As of physicians choice

  • First-line chemtherapyDrug

    As of physicians choice

Study groups in NCT06311383
Study groupRoleWhat they receive
First-line Ribociclib + endocrine therapyRibociclib + letrozole, or Ribociclib + anastrozole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
Receives: Drug: First-line Ribociclib + endocrine therapy
First-line endocrine therapyAs of physicians choice
Receives: Drug: First-line endocrine therapy
First-line chemotherapyAs of physicians choice
Receives: Drug: First-line chemtherapy

What is being measured

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

  1. 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.

    Measured: Up to 88 months

Secondary outcomes (13)

  1. 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.

    Measured: Up to 88 months

  2. 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.

    Measured: Up to 88 months

  3. 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.

    Measured: Up to 88 months

  4. 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.

    Measured: Up to 88 months

  5. 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.

    Measured: Up to 88 months

  6. Dose reduction

    Dose reduction rates and reasons

    Measured: Up to 88 months

  7. Dose interruption

    Dose interruption rates and reasons

    Measured: Up to 88 months

  8. Discontinuations

    Discontinuations rates and reasons

    Measured: Up to 88 months

  9. 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)

    Measured: Up to 87 weeks

  10. Number of participants with mutations

    Number of participants with mutations will be collected

    Measured: Up to 88 months

  11. 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.

    Measured: Up to 88 months

  12. 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.

    Measured: Up to 88 months

  13. 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.

    Measured: Up to 88 months

Timeline

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

  1. First posted15 Mar 2024
  2. Study start9 Oct 2017
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

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
2,610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06311383
Sponsor's protocol ID
CLEE011ADE03
Acronym
RIBANNA
Status last verified
Jan 2026
First submitted
29 Dec 2023
Last updated
27 Jan 2026
Results posted
No
Individual data sharing
No

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.

    PubMed 40381382

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 265 sites in Germany.

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 10 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 265 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to 88 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 NCT06311383, which also lists 1 linked publication.

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 27 Jan 2026.

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