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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
Led by Novartis Pharmaceuticals · Updated on 2026-04-20
2766
Participants Needed
37
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent within 28 days after starting ribociclib with aromatase inhibitors (± GnRH agonists) for the prospective cohort
- Age 18 years or older at consent or hormone therapy start
- Histologically confirmed HR+ HER2-negative stage II-III breast cancer treated with radical therapy
- Hormone therapy with aromatase inhibitors (± GnRH agonists) started no earlier than 12 months before ribociclib
- ECOG performance status 0-1
- For the retrospective cohort: hormone therapy with aromatase inhibitors (± GnRH agonists) started between July 1, 2019 and July 1, 2020
- Availability of necessary source documentation
You will not qualify if you...
- Prior treatment with abemaciclib or palbociclib
- Ribociclib with aromatase inhibitors therapy exceeding 28 days before consent in the prospective cohort
- Active treatment for other cancers
- Participation in interventional clinical studies at consent or during breast cancer treatment
- Neoadjuvant or adjuvant CDK4/6 inhibitor therapy in the retrospective cohort
- History of other malignant neoplasms requiring active treatment
- Recurrence during hormone therapy allowed only if other criteria are met
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 37 locations
1
Novartis Investigative Site
Kaluga, Russia, Russia, 248007
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2
Novartis Investigative Site
Ryazan, Russia, Russia, 390011
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3
Novartis Investigative Site
Surgut, Tymen Area, Russia, 628402
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4
Novartis Investigative Site
Arkhangelsk, Russia, 163045
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5
Novartis Investigative Site
Barnaul, Russia, 656045
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6
Novartis Investigative Site
Bryansk, Russia, 241028
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7
Novartis Investigative Site
Irkutsk, Russia, 664035
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8
Novartis Investigative Site
Ivanovo, Russia, 153040
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9
Novartis Investigative Site
Izhevsk, Russia, 426009
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10
Novartis Investigative Site
Kemerovo, Russia, 650036
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11
Novartis Investigative Site
Khabarovsk, Russia, 680042
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12
Novartis Investigative Site
Khanty-Mansiysk, Russia, 628012
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13
Novartis Investigative Site
Khimky, Russia, 121552
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14
Novartis Investigative Site
Kirov, Russia, 610021
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15
Novartis Investigative Site
Krasnoyarsk, Russia, 660022
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16
Novartis Investigative Site
Moscow, Russia, 115304
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17
Novartis Investigative Site
Moscow, Russia, 115522
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18
Novartis Investigative Site
Moscow, Russia, 125284
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19
Novartis Investigative Site
Moscow, Russia, 129110
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20
Novartis Investigative Site
Moscow Region Balas, Russia, 143900
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21
Novartis Investigative Site
Perm, Russia, 614066
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22
Novartis Investigative Site
Pyatigorsk, Russia, 357502
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23
Novartis Investigative Site
Rostov-on-Don, Russia, 344006
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24
Novartis Investigative Site
Saint Petersburg, Russia, 194017
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25
Novartis Investigative Site
Saint Petersburg, Russia, 194291
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26
Novartis Investigative Site
Saint Petersburg, Russia, 197758
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27
Novartis Investigative Site
Saransk, Russia, 430032
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28
Novartis Investigative Site
Tver', Russia, 170008
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29
Novartis Investigative Site
Tyumen, Russia, 625023
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30
Novartis Investigative Site
Ufa, Russia, 450054
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31
Novartis Investigative Site
Vladikavkaz, Russia, 362002
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32
Novartis Investigative Site
Vladivostok, Russia, 690105
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33
Novartis Investigative Site
Volgograd, Russia, 400138
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34
Novartis Investigative Site
Voronezh, Russia, 394036
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35
Novartis Investigative Site
Yaroslavl, Russia, 150054
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36
Novartis Investigative Site
Yekaterinburg, Russia, 620036
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37
Novartis Investigative Site
Yuzhno-Sakhalinsk, Russia, 693010
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Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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