Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia
This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with…
Conditions studied
Breast Cancer
About this study
This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.
Interventions
- Drug: Ribociclib — CDK4/6 inhibitor
- Drug: Letrozole — Aromatase inhibitor
- Drug: Anastrozole — Aromatase inhibitor
Primary outcomes
- Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort (Months 36, 48, 60)
Eligibility information
Study locations
- Novartis Investigative Site, Sochi, Russian Federation 354057 Russia
- Novartis Investigative Site, Kaluga, Russia 248007 Russia
- Novartis Investigative Site, Pskov, Russia 180000 Russia
- Novartis Investigative Site, Ryazan, Russia 390011 Russia
- Novartis Investigative Site, Saint Petersburg, Russia 197758 Russia
- Novartis Investigative Site, Surgut, Tymen Area 628402 Russia
- Novartis Investigative Site, Arkhangelsk, 163045 Russia
- Novartis Investigative Site, Barnaul, 656045 Russia
- Novartis Investigative Site, Bryansk, 241028 Russia
- Novartis Investigative Site, Irkutsk, 664035 Russia
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Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.