Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France

This study is a national, multicenter, prospective, non-interventional study in women with HR+/HER2- locally advanced or metastatic breast cancer (BC), for which a prior clinical decision to initiate ribociclib + endocrine therapy (ET) treatment according to the marketing authorization has been taken and was taken independent and prior to study participation decision.

Inclusion Criteria:Patients who meet all of the following criteria will be included in the RosaLEE study:Adult women aged ≥ 18 years old at inclusion.Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC.Prior clinical decision (independent of study participation)to initiate ribociclib + ET treatment according to the marketing authorization.Patients having given their non-objection to participate in the study.Patients presenting with medical conditions to be treated with ribociclib + ET according to the summary of product characteristics.Exclusion Criteria:Patients for whom ribociclib + AI in treatment combination has been initiated before inclusion.Patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion.Patients for whom AI or fulvestrant in monotherapy has been initiated > 28 days before inclusion.Participation in any clinical study involving investigational therapy except for the Trans-RosaLEE study, conducted by the IPC.Patient who is pregnant or has expressed desire for pregnancy during Ribociclib treatment.