NCT06625333

A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 329 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia.

Detailed description

In this study, an index event is a start of ribociclib+ET treatment. Post-index follow-up period is 24 months or until treatment discontinuation. The recruitment period is planned for 12 months. The interim analyses will be performed after enrollment is complete, and further one year later. Patients will visit the sites in accordance with routine clinical practice. It is assumed according to the clinical practice that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement.

Conditions

• HR+HER2- Advanced Breast Cancer

Timeline

• Start date: 2024-10-11
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-10-03
• Last updated: 2026-04-01

Locations

20 sites across 1 country: Russia