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
NCT ID: NCT06311383
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2610 participants
OBSERVATIONAL
2017-10-09
2025-02-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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First-line Ribociclib + endocrine therapy
Ribociclib + letrozole, or Ribociclib + anastrozole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
First-line Ribociclib + endocrine therapy
Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
First-line endocrine therapy
As of physicians choice
First-line endocrine therapy
As of physicians choice
First-line chemotherapy
As of physicians choice
First-line chemtherapy
As of physicians choice
Interventions
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First-line Ribociclib + endocrine therapy
Ribociclib + letrozole, or Ribociclib + anastrazole, or Ribociclib + exemestane, or Ribociclib + fulvestrant
First-line endocrine therapy
As of physicians choice
First-line chemtherapy
As of physicians choice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Baden-Baden, Baden-Wurttemberg, Germany
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Freudenstadt, Baden-Wurttemberg, Germany
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Heidenheim, Baden-Wurttemberg, Germany
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Karlsruhe, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Mutlangen, Baden-Wurttemberg, Germany
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Nürtingen, Baden-Wurttemberg, Germany
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Ostfildern, Baden-Wurttemberg, Germany
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Reutlingen, Baden-Wurttemberg, Germany
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Rottweil, Baden-Wurttemberg, Germany
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Schwaebisch, Baden-Wurttemberg, Germany
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Sigmaringen, Baden-Wurttemberg, Germany
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Winnenden, Baden-Wurttemberg, Germany
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Altötting, Bavaria, Germany
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Amberg, Bavaria, Germany
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Ansbach, Bavaria, Germany
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Aschaffenburg, Bavaria, Germany
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Augsburg, Bavaria, Germany
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Bamberg, Bavaria, Germany
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Bayreuth, Bavaria, Germany
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Donauwörth, Bavaria, Germany
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Ebersberg, Bavaria, Germany
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Eggenfelden, Bavaria, Germany
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Kempten (Allgäu), Bavaria, Germany
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Kronach, Bavaria, Germany
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Krumbach, Bavaria, Germany
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Landshut, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Munich, Bavaria, Germany
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Nuremberg, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Straubing, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Mannheim, Beden Wuerttenberg, Germany
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Brandenburg, Brandenburg, Germany
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Cottbus, Brandenburg, Germany
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Doberlug-Kirchhain, Brandenburg, Germany
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Fürstenwalde, Brandenburg, Germany
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Ludwigsfelde, Brandenburg, Germany
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Neu-Brandenburg, Brandenburg, Germany
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Spremberg, Brandenburg, Germany
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Bremen, City state Bremen, Germany
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Bremen, City state Bremen, Germany
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Bremerhaven, City state Bremen, Germany
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Schwerte, Germany, Germany
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Wiesbaden, Germany, Germany
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Hamburg, Hamburg, Germany
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Hamburg, Hamburg, Germany
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Hamburg, Hamburg, Germany
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Bad Homburg, Hesse, Germany
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Bad Nauheim, Hesse, Germany
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Darmstadt, Hesse, Germany
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Erbach im Odenwald, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Langen, Hesse, Germany
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Lich, Hesse, Germany
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Marburg, Hesse, Germany
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Braunschweig, Lower Saxony, Germany
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Buchholz, Lower Saxony, Germany
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Damme, Lower Saxony, Germany
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Georgsmarienhütte, Lower Saxony, Germany
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Hamelin, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Hildesheim, Lower Saxony, Germany
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Ilsede, Lower Saxony, Germany
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Lingen Ems, Lower Saxony, Germany
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Osnabrück, Lower Saxony, Germany
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Quedlinburg, Lower Saxony, Germany
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Twistringen, Lower Saxony, Germany
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Westerstede, Lower Saxony, Germany
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Wolfenbüttel, Lower Saxony, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Stralsund, Mecklenburg-Vorpommern, Germany
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Arnsberg, North Rhine-Westphalia, Germany
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Bergisch Gladbach, North Rhine-Westphalia, Germany
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Bielefeld, North Rhine-Westphalia, Germany
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Bielefeld, North Rhine-Westphalia, Germany
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Bochum, North Rhine-Westphalia, Germany
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Bonn, North Rhine-Westphalia, Germany
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Bonn, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Gelsenkirchen, North Rhine-Westphalia, Germany
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Hagen, North Rhine-Westphalia, Germany
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Herdecke, North Rhine-Westphalia, Germany
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Herne, North Rhine-Westphalia, Germany
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Hilden, North Rhine-Westphalia, Germany
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Krefeld, North Rhine-Westphalia, Germany
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Lemgo, North Rhine-Westphalia, Germany
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Mönchengladbach, North Rhine-Westphalia, Germany
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Olpe, North Rhine-Westphalia, Germany
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Paderborn, North Rhine-Westphalia, Germany
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Remscheid, North Rhine-Westphalia, Germany
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Siegen, North Rhine-Westphalia, Germany
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Troisdorf, North Rhine-Westphalia, Germany
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Velbert, North Rhine-Westphalia, Germany
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Wesel, North Rhine-Westphalia, Germany
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Wesel, North Rhine-Westphalia, Germany
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Witten, North Rhine-Westphalia, Germany
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Remscheid Innen, Northrhine Westfalia, Germany
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Mayen, Rhineland-Palatinate, Germany
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Neustadt, Rhineland-Palatinate, Germany
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Simmern, Rhineland-Palatinate, Germany
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Lebach, Saarland, Germany
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Dresden, Saxony, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Lohsa-Weisskollm, Saxony, Germany
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Pirna, Saxony, Germany
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Rodewisch, Saxony, Germany
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Scheibenberg, Saxony, Germany
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Schkeuditz, Saxony, Germany
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Zittau, Saxony, Germany
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Zxickau, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Flensburg, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Apolda, Thuringia, Germany
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Eisenach, Thuringia, Germany
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Erfurt, Thuringia, Germany
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Jena, Thuringia, Germany
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Meiningen, Thuringia, Germany
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Mühlhausen, Thuringia, Germany
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Suhl, Thuringia, Germany
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Altötting, , Germany
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Augsburg, , Germany
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Augsburg, , Germany
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Bad Liebenwerda, , Germany
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Bamberg, , Germany
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Bayreuth, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Bonn, , Germany
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Bottrop, , Germany
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Böblingen, , Germany
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Brandenburg, , Germany
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Bremen, , Germany
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Bremerhaven, , Germany
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Celle, , Germany
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Chemnitz, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Cologne, , Germany
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Cologne, , Germany
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Dessau, , Germany
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Dresden, , Germany
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Erfurt, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Eutin, , Germany
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Friedberg, , Germany
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Friedrichshafen, , Germany
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Gera, , Germany
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Goch, , Germany
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Goslar, , Germany
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Göttingen, , Germany
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Göttingen, , Germany
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Greifswald, , Germany
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Gummersbach, , Germany
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Halberstadt, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamelin, , Germany
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Hanau, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Hof, , Germany
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Homburg, , Germany
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Kaiserslautern, , Germany
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Karlsruhe, , Germany
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Karlsruhe, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Koblenz, , Germany
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Kulmbach, , Germany
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Leipzig, , Germany
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Loerrach, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Marburg, , Germany
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Marktredwitz, , Germany
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Memmingen, , Germany
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Minden, , Germany
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Moers, , Germany
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Münster, , Germany
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Naunhof, , Germany
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Neuruppin, , Germany
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Neuss, , Germany
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Neuss, , Germany
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Neustadt Sachsen, , Germany
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Nordhausen, , Germany
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Nuremberg, , Germany
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Nuremberg, , Germany
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Offenbach, , Germany
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Offenburg, , Germany
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Oldenburg, , Germany
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Osnabrück, , Germany
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Passau, , Germany
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Pforzheim, , Germany
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Plauen Kauschwitz, , Germany
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Potsdam, , Germany
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Ravensburg, , Germany
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Regensburg, , Germany
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Rheine, , Germany
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Rodgau, , Germany
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Rosenheim, , Germany
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Rostock, , Germany
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Rostock, , Germany
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Rotenburg (Wümme), , Germany
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Rüsselsheim am Main, , Germany
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Saarbrücken, , Germany
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Saarlouis, , Germany
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Salzgitter, , Germany
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Schkeuditz, , Germany
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Schorndorf, , Germany
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Schwäbisch Hall, , Germany
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Schweinfurt, , Germany
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Soest, , Germany
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Stade, , Germany
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Stendal, , Germany
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Stolberg, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Suhl, , Germany
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Torgau, , Germany
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Trier, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Ulm, , Germany
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Vechta, , Germany
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Völklingen, , Germany
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Weiden, , Germany
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Weinheim, , Germany
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Wetzlar, , Germany
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Wiesbaden, , Germany
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Wilhelmshaven, , Germany
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Wolfsburg, , Germany
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Worms, , Germany
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Würselen, , Germany
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Würzburg, , Germany
Countries
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References
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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.
Other Identifiers
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CLEE011ADE03
Identifier Type: -
Identifier Source: org_study_id