Study of Ribociclib with Standard Endocrine Therapy in Women with Advanced HRHER2- Breast Cancer

What this Trial Is About

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients