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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • ribociclib + AI ± LHRH
  • abemaciclib + ET ± LHRH
  • ET mono ± LHRH

Treatment groups

3,250 Participants
are divided into 3 treatment groups

Locations

283
Austria
Novartis Investigative Site2700, Wiener NeustadtLower Austria, Austria
Novartis Investigative Site6020, InnsbruckTyrol, Austria
Novartis Investigative Site4010, LinzUpper Austria, Austria
Novartis Investigative Site8036, Graz Austria

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor