Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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
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

NCT06830720

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Breast Neoplasms

Interventions: ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, ET mono ± LHRH

Countries: Austria, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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 + 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

Exclusion Criteria:

\- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.
Locations (287)
  • Wiener Neustadt, Lower Austria, Austria
  • Innsbruck, Tyrol, Austria
  • Linz, Upper Austria, Austria
  • Graz, Austria
  • Klagenfurt, Austria
  • Leoben, Austria
  • Schwaz, Austria
  • Steyr, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Baden-Baden, Baden-Wurttemberg, Germany
  • Filderstadt, Baden-Wurttemberg, Germany
  • Freudenstadt, Baden-Wurttemberg, Germany
  • Heidelberg, Baden-Wurttemberg, Germany
  • Heidenheim, Baden-Wurttemberg, Germany
  • Konstanz, Baden-Wurttemberg, Germany
  • Mannheim, Baden-Wurttemberg, Germany
  • Mannheim, Baden-Wurttemberg, Germany
  • Nürtingen, Baden-Wurttemberg, Germany
  • Ostfildern, Baden-Wurttemberg, Germany
  • Pforzheim, Baden-Wurttemberg, Germany
  • Ravensburg, Baden-Wurttemberg, Germany
  • Reutlingen, Baden-Wurttemberg, Germany
  • Schwäbisch Hall, Baden-Wurttemberg, Germany
  • Villingen-Schwenningen, Baden-Wurttemberg, Germany
  • Winnenden, Baden-Wurttemberg, Germany
  • Altötting, Bavaria, Germany
  • Ansbach, Bavaria, Germany
  • + 257 more on CT.gov