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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
Sponsor: Novartis Pharmaceuticals
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
2766
Start Date
2025-12-22
Completion Date
2032-12-31
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Ribociclib
CDK4/6 inhibitor
Letrozole
Aromatase inhibitor
Anastrozole
Aromatase inhibitor
Locations (34)
Novartis Investigative Site
Kaluga, Russia, Russia
Novartis Investigative Site
Ryazan, Russia, Russia
Novartis Investigative Site
Surgut, Tymen Area, Russia
Novartis Investigative Site
Arkhangelsk, Russia
Novartis Investigative Site
Barnaul, Russia
Novartis Investigative Site
Irkutsk, Russia
Novartis Investigative Site
Ivanovo, Russia
Novartis Investigative Site
Izhevsk, Russia
Novartis Investigative Site
Kemerovo, Russia
Novartis Investigative Site
Khabarovsk, Russia
Novartis Investigative Site
Khimky, Russia
Novartis Investigative Site
Kirov, Russia
Novartis Investigative Site
Krasnoyarsk, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow Region Balas, Russia
Novartis Investigative Site
Perm, Russia
Novartis Investigative Site
Pyatigorsk, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Saransk, Russia
Novartis Investigative Site
Tver', Russia
Novartis Investigative Site
Tyumen, Russia
Novartis Investigative Site
Ufa, Russia
Novartis Investigative Site
Vladikavkaz, Russia
Novartis Investigative Site
Vladivostok, Russia
Novartis Investigative Site
Volgograd, Russia
Novartis Investigative Site
Voronezh, Russia
Novartis Investigative Site
Yaroslavl, Russia
Novartis Investigative Site
Yekaterinburg, Russia
Novartis Investigative Site
Yuzhno-Sakhalinsk, Russia