Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France: a National, Multicenter, Prospective, Non-interventional Study
ClinicalTrials.gov Identifier: NCT05697146
Novartis Reference Number: CLEE011AFR01
Last Update: Mar 27, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
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.
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.