This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.
Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with cycline dependent kinase 4/6 (CDK4/6) inhibitors is allowed in the adjuvant setting)
Written informed consent prior to beginning of trial specific procedures
Subject must be female and aged ≥ 18 years on the day of signing informed consent
Locally advanced or metastatic breast cancer not amenable to curative treatment
Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer
Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.
Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion
Patients who are pregnant or lactating.
Institut fuer Frauengesundheit
Lead sponsor
AGO Breast Study Group e.V.
Collaborator
Novartis Pharmaceuticals
Collaborator