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

Inclusion Criteria:

Patients who meet all of the following criteria will be included in the RosaLEE study:

1. Adult women aged ≥ 18 years old at inclusion.

2. Pre-/Peri-/Postmenopausal women with locally advanced or metastatic HR+/HER2- BC.

3. Prior clinical decision (independent of study participation)to initiate ribociclib +
ET treatment according to the marketing authorization.

4. Patients having given their non-objection to participate in the study.

5. Patients presenting with medical conditions to be treated with ribociclib + ET
according to the summary of product characteristics.

Exclusion Criteria:

1. Patients for whom ribociclib + AI in treatment combination has been initiated before
inclusion.

2. Patients for whom ribociclib + fulvestrant in treatment combination has been
initiated before inclusion.

3. Patients for whom AI or fulvestrant in monotherapy has been initiated > 28 days
before inclusion.

4. Participation in any clinical study involving investigational therapy except for the
Trans-RosaLEE study, conducted by the IPC.

5. Patient who is pregnant or has expressed desire for pregnancy during Ribociclib
treatment.