early breast cancer (EBC)., HER2-negative, hormone receptor (HR)-positive
Conditions
Brief summary
iDFS using STEEP criteria, as assessed by Investigator
Detailed description
RFS using STEEP criteria, DDFS using STEEP criteria, OS defined as time from date of randomization to date of death due to any cause, Change from baseline in the physical functioning sub-scale score and global health status/ QoL scale score as assessed by EORTC QLQ-C30, Frequency and severity of AEs, laboratory and Electrocardiogram (ECG) abnormalities, PK parameters such as Ctrough and other applicable parameters for ribociclib
Interventions
DRUGGOSERELIN
DRUGLETROZOLE
DRUGANASTROZOLE
DRUGRIBOCICLIB
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iDFS using STEEP criteria, as assessed by Investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| RFS using STEEP criteria, DDFS using STEEP criteria, OS defined as time from date of randomization to date of death due to any cause, Change from baseline in the physical functioning sub-scale score and global health status/ QoL scale score as assessed by EORTC QLQ-C30, Frequency and severity of AEs, laboratory and Electrocardiogram (ECG) abnormalities, PK parameters such as Ctrough and other applicable parameters for ribociclib | — |
Countries
Austria, Belgium, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Spain
Outcome results
None listed