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.
Single group
Ribociclib
DrugAll patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard. Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day. Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.
12-month PFS rate
The rate for progression-free survival at month 12 will be calculated.
12-month OS rate
The rate for overall survival at month 12 will be calculated.
24-month PFS rate
The rate for progression-free survival at month 24 will be calculated.
24-month OS rate
The rate for overall survival at month 24 will be calculated.
36-month PFS rate
The rate for progression-free survival at month 36 will be calculated.
36-month OS rate
The rate for overall survival at month 36 will be calculated.
Correlation of genome wide genetic biomarkers with progression-free survival
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Correlation of genome wide genetic biomarkers with overall survival
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Correlation of genome wide genetic biomarkers with quality of life
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
Correlation of genome wide genetic biomarkers with ribociclib side effects
Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.
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Institut fuer Frauengesundheit
Lead sponsor
AGO Breast Study Group e.V.
Collaborator
Novartis Pharmaceuticals
Collaborator
