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 25, 2025
Recruiting
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported