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Search / Trial NCT06830720

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

Launched by NOVARTIS PHARMACEUTICALS · Feb 12, 2025

Trial Information

Current as of September 04, 2025

Recruiting

Keywords

Non Interventional Study Nis Breast Cancer Early Breast Cancer Hr+ Her Ribociclib Real World Evidence Adjuvant Therapy

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called ribociclib when used with another drug, an aromatase inhibitor, in patients with a specific type of early breast cancer (HR+/HER2-). The goal is to find out how well this combination works for patients who are at high risk of their cancer coming back after initial treatment. The study also looks at how well patients stick to their treatment plans and how it impacts their quality of life.

To participate in this trial, patients need to be 18 years or older and have a confirmed diagnosis of HR+/HER2- early breast cancer. They should be starting treatment with ribociclib and an aromatase inhibitor or other specified treatments. Patients who are currently involved in other clinical trials or have received certain previous treatments may not be eligible. Those who join the study can expect to be monitored closely by their healthcare team, and their experiences will help researchers understand the best ways to use these medications in real-world settings.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Histological diagnosis of HR+/HER2- early breast cancer with curative intent
  • Patients must have an indication for a treatment with ribociclib + NSAI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + NSAI ± 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 + NSAI ± 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 + NSAI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: 4 weeks after therapy start or 4 weeks after last non-endocrine based therapy, whichever is last.
  • ≥18 years of age
  • Written informed consent
  • Exclusion Criteria:
  • Patient is currently under active treatment in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib
  • For ribociclib + NSAI ± LHRH cohort: ET pre-treatment is longer than 12 months, according to the current SmPC/"Fachinformation" of ribociclib; for abemaciclib + ET ± LHRH cohort: ET pre-treatment is longer than 12 weeks, according to the current SmPC/"Fachinformation" of abemaciclib

About Novartis Pharmaceuticals

Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.

Locations

Augsburg, , Germany

Essen, , Germany

Trier, , Germany

Ulm, , Germany

Bayreuth, Bayern, Germany

Muenchen, Bayern, Germany

Hamburg, , Germany

Leipzig, , Germany

Amberg, , Germany

Freiburg, , Germany

Homburg, , Germany

Jena, , Germany

Tuebingen, , Germany

Witten, , Germany

Magdeburg, Sachsen Anhalt, Germany

Boeblingen, , Germany

Celle, , Germany

Halle, , Germany

Kempten, , Germany

Ulm, , Germany

Weiden, , Germany

Bad Reichenhall, , Germany

Ansbach, Bayern, Germany

Donauwoerth, Bayern, Germany

Ebersberg, Bayern, Germany

Fuerth, Bayern, Germany

Kronach, Bayern, Germany

Rosenheim, Bayern, Germany

Traunstein, Bayern, Germany

Waldmuenchen, Bayern, Germany

Wiesbaden, Hessen, Germany

Braunschweig, Niedersachsen, Germany

Georgsmarienhuette, Niedersachsen, Germany

Westerstede, Niedersachsen, Germany

Dresden, Sachsen, Germany

Schkeuditz, Sachsen, Germany

Zittau, Sachsen, Germany

Muehlhausen, Thueringen, Germany

Berlin, , Germany

Brandenburg, , Germany

Bremen, , Germany

Aachen, , Germany

Dresden, , Germany

Hagen, , Germany

Erfurt, , Germany

Leipzig, Sachsen, Germany

Hennigsdorf, , Germany

Muenchen, Bayern, Germany

Wuerzburg, Bayern, Germany

Bamberg, , Germany

Bonn, , Germany

Neuss, , Germany

Chemnitz, , Germany

Heilbronn, , Germany

Hildesheim, Niedersachsen, Germany

Bad Mergentheim, , Germany

Dessau Rosslau, , Germany

Muenster, , Germany

Gerlingen, , Germany

Bad Nauheim, Hessen, Germany

Bottrop, , Germany

Eschweiler, , Germany

Goslar, , Germany

Karlsruhe, , Germany

Moers, , Germany

Mutlangen, , Germany

Nuernberg, , Germany

Schorndorf, , Germany

Marburg, Hessen, Germany

Gummersbach, , Germany

Oldenburg, , Germany

Chemnitz, , Germany

Krefeld, , Germany

Stuttgart, , Germany

Singen, , Germany

Gera, , Germany

Muehlhausen, , Germany

Koeln, , Germany

Bonn, , Germany

Eggenfelden, , Germany

Flensburg, Schleswig Holstein, Germany

Bruchsal, , Germany

Nordhausen, , Germany

Stralsund, , Germany

Langen, Hessen, Germany

Luebeck, Schleswig Holstein, Germany

Hannover, , Germany

Fuerstenwalde, , Germany

Soest, , Germany

Balingen, , Germany

Offenburg, , Germany

Weinheim, , Germany

Rotenburg, , Germany

Suhl, , Germany

Torgau, , Germany

Guenzburg, , Germany

Biberach, , Germany

Erfurt, , Germany

Passau, , Germany

Schweinfurt, , Germany

Kulmbach, , Germany

Moenchengladbach, , Germany

Jena, , Germany

Prien A Chiemsee, , Germany

Bochum, Nordrhein Westfalen, Germany

Velbert, North Rhine Westphalia, Germany

Muenchen, Bavaria, Germany

Neubrandenburg, , Germany

Bautzen, , Germany

Ehingen, , Germany

Freudenstadt, Baden Wuerttemberg, Germany

Wesel, , Germany

Winnenden, Baden Wuerttemberg, Germany

Bonn, Nordrhein Westfalen, Germany

Naunhof, , Germany

Heide, , Germany

Twistringen, Lower Saxony, Germany

Reutlingen, Baden Wuerttemberg, Germany

Herrsching, Bavaria, Germany

Loerrach, , Germany

Mannheim, Baden Wuerttemberg, Germany

Nuertingen, Baden Wuerttemberg, Germany

Altoetting, Bayern, Germany

Bremerhaven, Bremen, Germany

Bad Homburg, Hessen, Germany

Rostock, Mecklenburg Vorpommern, Germany

Osnabrueck, Niedersachsen, Germany

Wolfenbuettel, Niedersachsen, Germany

Bergisch Gladbach, Nordrhein Westfalen, Germany

Bielefeld, Nordrhein Westfalen, Germany

Bonn, Nordrhein Westfalen, Germany

Dortmund, Nordrhein Westfalen, Germany

Duesseldorf, Nordrhein Westfalen, Germany

Paderborn, Nordrhein Westfalen, Germany

Siegen, Nordrhein Westfalen, Germany

Remscheid, Nordrhein Westfalen, Germany

Magdeburg, Sachsen Anhalt, Germany

Scheibenberg, Sachsen, Germany

Berlin, , Germany

Marktredwitz, , Germany

Plauen Kauschwitz, , Germany

Troisdorf, Nordrhein Westfalen, Germany

Ravensburg, Baden Wuerttemberg, Germany

Schwaebisch, Baden Wuerttemberg, Germany

Hildesheim, Lower Saxony, Germany

Wunstorf, Niedersachsen, Germany

Salzwedel, Sachsen, Germany

Bad Langensalza, , Germany

Ehrenfriedersdorf, , Germany

Hamburg, , Germany

Neustadt In Sachsen, , Germany

Werdau, , Germany

Frankfurt Am Main, Hessen, Germany

Halle Saale, Sachsen Anhalt, Germany

Filderstadt, Baden Wuerttemberg, Germany

Heidenheim, Baden Wuerttemberg, Germany

Pforzheim, Baden Wuerttemberg, Germany

Halle, Sachsen Anhalt, Germany

Duesseldorf, , Germany

Rostock, , Germany

Waldkirchen, , Germany

Sigmaringen, , Germany

Cottbus, Brandenburg, Germany

Ilsede, Niedersachsen, Germany

Koeln, Nordrhein Westfalen, Germany

Apolda, , Germany

Potsdam, , Germany

Saalfeld Saale, , Germany

Waldsassen, , Germany

Winse Luhe, , Germany

Munich, Bavaria, Germany

Augsburg, Bayern, Germany

Goettingen, Niedersachsen, Germany

Lebach, Saarland, Germany

Stendal, Sachsen Anhalt, Germany

Dillingen A D Donau, , Germany

Mannheim, Baden Wuerttemberg, Germany

Landsberg Am Lech, Bayern, Germany

Halle Saale, Sachsen Anhalt, Germany

Speyer, Rheinland Pfalz, Germany

Borna, Sachsen, Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported