Patients with advanced hormone receptor-positive/HER2- negative/HER2-Enriched breast cancer
Conditions
Brief summary
Progression-free survival using RECIST 1.1 criteria, as assessed by local radiologists/investigators
Detailed description
To compare the two treatment arms with respect to PFS2 in the HER2-E cohort, To compare the two treatment arms with respect to overall survival in the HER2-E cohort, To evaluate the two treatment arms with respect to ORR and clinical benefit rate (CBR) in HER2-E patients, where CBR, defined as percentage of patients with CR, PR per RECIST or SD lasting 24 weeks or longer., To evaluate the safety and tolerability of ribociclib and palbociclib in combination with endocrine therapy the HER2-E cohort, To evaluate patient reported outcomes for health-related quality of life in the two treatment arms of the HER2-E cohort., To describe time to response and duration of response in each treatment arm.
Interventions
Sponsors
Solti Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival using RECIST 1.1 criteria, as assessed by local radiologists/investigators | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the two treatment arms with respect to PFS2 in the HER2-E cohort, To compare the two treatment arms with respect to overall survival in the HER2-E cohort, To evaluate the two treatment arms with respect to ORR and clinical benefit rate (CBR) in HER2-E patients, where CBR, defined as percentage of patients with CR, PR per RECIST or SD lasting 24 weeks or longer., To evaluate the safety and tolerability of ribociclib and palbociclib in combination with endocrine therapy the HER2-E cohort, To evaluate patient reported outcomes for health-related quality of life in the two treatment arms of the HER2-E cohort., To describe time to response and duration of response in each treatment arm. | — |
Countries
Portugal, Spain
Outcome results
None listed