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

Recruiting now

Conditions studied: Breast Neoplasms

In brief

This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.

Key facts

Study ID

NCT06830720

Run by

Novartis Pharmaceuticals

People needed

3250

Starts

2025-02-20

Expected to finish

2030-06-30

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of HR+/HER2- early breast cancer with curative intent
• Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± 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 + AI ± 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 + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.
• ≥18 years of age
• Written informed consent

You may not qualify if…

• Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.

Where it is running

• Novartis Investigative Site — Innsbruck, Tyrol, Austria (enrolling)
• Novartis Investigative Site — Linz, Upper Austria, Austria (enrolling)
• Novartis Investigative Site — Graz, Austria (enrolling)
• Novartis Investigative Site — Klagenfurt, Austria (enrolling)
• Novartis Investigative Site — Leoben, Austria (enrolling)
• Novartis Investigative Site — Schwaz, Austria (enrolling)
• Novartis Investigative Site — Steyr, Austria (enrolling)
• Novartis Investigative Site — Vienna, Austria (enrolling)
• Novartis Investigative Site — Vienna, Austria (enrolling)
• Novartis Investigative Site — Vienna, Austria (enrolling)
• Novartis Investigative Site — Vienna, Austria (enrolling)
• Novartis Investigative Site — Baden-Baden, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Filderstadt, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Freudenstadt, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Heidenheim, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Konstanz, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Mannheim, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Mannheim, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Nürtingen, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Ostfildern, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Pforzheim, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Ravensburg, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Reutlingen, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Wiener Neustadt, Lower Austria, Austria (enrolling)

Full record on ClinicalTrials.gov

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