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RECRUITING
NCT06930859

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

View on ClinicalTrials.gov

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

DRUG

Ribociclib

CDK4/6 inhibitor

DRUG

Letrozole

Aromatase inhibitor

DRUG

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