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
NCT: NCT06625333 ·
Status: ACTIVE NOT RECRUITING ·
Phase: N/A
· Sponsor: Novartis Pharmaceuticals
· Started: 2024-10-11
· Est. Completion: 2027-12-31
Official 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.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 329 participants
Primary Outcomes
- change of QoL (RAND SF-36) (from baseline to the level at 12 months)
Secondary Outcomes
- Time to treatment failure (TTF) (up to two years)
- Progression free survival rate (PFS) (up to two years)
- Median progression free survival (up tp two years)
- Overall survival rate (OS) (up to two years)
- Objective response rate (ORR) (up to two years)
Trial Locations
- Novartis Investigative Site, Arkhangelsk, Russia
- Novartis Investigative Site, Barnaul, Russia
- Novartis Investigative Site, Bryansk, Russia
- Novartis Investigative Site, Chelyabinsk, Russia
- Novartis Investigative Site, Irkutsk, Russia
- Novartis Investigative Site, Kemerovo, Russia
- Novartis Investigative Site, Khabarovsk, Russia
- Novartis Investigative Site, Khanty-Mansiysk, Russia
- Novartis Investigative Site, Kirov, Russia
- Novartis Investigative Site, Krasnoyarsk, Russia
- ...and 10 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.