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

Sponsors and collaborators