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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony histologicznie rak piersi trzech pierwszych stadiów (II-III), dodatni na receptor hormonalny, ujemny na HER2
- •Przebyte radykalne leczenie chirurgiczne raka piersi
- •Ogólny stan zdrowia pozwalający na aktywność zwykłą lub lekko ograniczoną (stan 0-1)
- •Podpisana świadoma zgoda na udział w badaniu
- •Dla kohorty prospektywnej: rozpoczęcie terapii ribociclibu nie później niż 28 dni przed podpisaniem zgody
- •Dla kohorty retrospektywnej: rozpoczęcie terapii hormonalnej między 1 lipca 2019 a 1 lipca 2020
✗ Disqualifies
- •Historia stosowania abemaciclibu lub palbociclibu
- •Poprzednie leczenie innymi inhibitorami CDK4/6
- •Aktywne leczenie innego nowotworu złośliwego
- •Udział w innych badaniach klinicznych ze związkiem z badanym schematem leczenia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Last updated (source)
- June 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (40)
Novartis Investigative Site
Kaluga, Russia
Novartis Investigative Site
Pskov, Russia
Novartis Investigative Site
Ryazan, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Surgut, Russia
Novartis Investigative Site
Arkhangelsk, Russia
Novartis Investigative Site
Barnaul, Russia
Novartis Investigative Site
Bryansk, 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
Khanty-Mansiysk, 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
Rostov-on-Don, 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
Sestroretsk, 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
Trial contact
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.