RecruitingNCT06930859

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

Enrollment

2,766 participants

Start Date

Dec 22, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This observational study in Russia tracks the real-world effectiveness and safety of ribociclib (a targeted therapy) combined with hormone-blocking drugs (aromatase inhibitors) for women with hormone receptor-positive (HR+), HER2-negative Stage II or III breast cancer after surgery. **You may be eligible if...** - You are 18 years or older - You have HR-positive, HER2-negative Stage II or III breast cancer that was surgically removed - You are starting or recently started ribociclib combined with an aromatase inhibitor as part of standard care - You are in reasonably good health (ECOG performance status 0–1) **You may NOT be eligible if...** - You have previously received similar targeted drugs (abemaciclib or palbociclib) - You are actively being treated for another cancer - You are enrolled in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRibociclib

CDK4/6 inhibitor

DRUGLetrozole

Aromatase inhibitor

DRUGAnastrozole

Aromatase inhibitor


Locations(37)

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

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

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

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NCT06930859


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