Tumors of female reproductive systemTumors of female reproductive systemОпухоли женской репродуктивной системы1994-40981999-8627Publishing House ABV Press143510.17650/1994-4098-2025-21-4-71-84MAMMOLOGY. REVIEWSМАММОЛОГИЯ. ОБЗОРНЫЕ СТАТЬИReview ArticleFrom clinical trials to routine practice: 7-year results of the monarchE randomized clinical trial and experience with the use of abemaciclib in hormone-dependent, HER2-negative, high-risk, early breast cancerОт клинических исследований к рутинной практике: 7-летние результаты рандомизированного клинического исследования monarchE и опыт применения абемациклиба при гормонозависимом HER2-отрицательном раннем раке молочной железы высокого риска рецидиваhttps://orcid.org/0000-0002-1124-6802KolyadinaIrina V.КолядинаИрина Владимировна
Russian Federation

Member of the RSOM Board, MD, PhD, Leading Researcher, Professor of the Department of Oncology and Palliative Medicine, Member of the ESMO, ASCO

член РООМ, д.м.н., ведущий научный сотрудник, профессор кафедры онкологии и паллиативной медицины, член ESMO, ASCO

irinakolyadina@yandex.comhttps://orcid.org/0000-0002-4597-172XKhokhlovaS. V.ХохловаС. В.
Russian Federation
irinakolyadina@yandex.comhttps://orcid.org/0009-0000-3757-5025BikeevYu. V.БикеевЮ. В.
Russian Federation
irinakolyadina@yandex.comhttps://orcid.org/0000-0002-7303-7213ZaytsevN. A.ЗайцевН. А.
Russian Federation
irinakolyadina@yandex.comhttps://orcid.org/0000-0002-0995-1801PoddubnayaIrina V.ПоддубнаяИрина Владимировна
Russian Federation

MD, PhD, Professor, Corresponding Member of the Russian Academy of Sciences, Vice-Rector of Academic Affairs and International Cooperation, Head of the Department of Oncology

д.м.н., профессор, член-корреспондент РАН, проректор по учебной работе и международному сотрудничеству, заведующая кафедрой онкологии

irinakolyadina@yandex.comRussian Medical Academy of Postgraduate Education, Ministry of Health of RussiaФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава РоссииV. I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of RussiaФГБУ «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии им. акад. В. И. Кулакова» Минздрава России2001202621471842301202623012026Copyright ©; 2026, Kolyadina I.V., Khokhlova S.V., Bikeev Y.V., Zaytsev N.A., Poddubnaya I.V.Copyright ©; 2026, Колядина И.В., Хохлова С.В., Бикеев Ю.В., Зайцев Н.А., Поддубная И.В.2026Kolyadina I.V., Khokhlova S.V., Bikeev Y.V., Zaytsev N.A., Poddubnaya I.V.Колядина И.В., Хохлова С.В., Бикеев Ю.В., Зайцев Н.А., Поддубная И.В.https://creativecommons.org/licenses/by/4.0https://ojrs.abvpress.ru/ojrs/article/view/1435

The 7-year results of the monarchE randomized clinical trial of adjuvant endocrine therapy escalation with abemaciclib in patients with hormone-dependent, HER2-negative, high-risk, early breast cancer. Three-year experience with the use of abemaciclib in 64 patients with hormone-dependent, HER2-negative, early breast cancer in real-world practice is analyzed, and the criteria for selecting combination endocrine therapy and the safety profile of treatment escalation are assessed. An indirect comparison of data from the Russian analysis and the randomized clinical monarchE trial of adjuvant endocrine therapy escalation in patients with a high risk of recurrence is conducted. Clinical cases of abemaciclib use in routine practice in Russian patients are presented.

Представлены 7-летние результаты рандомизированного клинического исследования monarchE по эскалации адъювантной эндокринотерапии с абемациклибом у пациентов с ранним гормонозависимым HER2-отрицательным раком молочной железы высокого риска рецидива. Проанализирован 3-летний опыт применения абемациклиба у 64 больных в реальной практике при раннем гормонозависимом HER2-отрицательном раке молочной железы, оценены критерии выбора комбинированной эндокринотерапии, а также профиль безопасности при эскалации лечения. Проведено непрямое сравнение данных российского анализа и рандомизированного клинического исследования monarchE по эскалации адъювантной эндокринотерапии у пациентов группы высокого риска рецидива. Представлены клинические случаи применения абемациклиба в рутинной практике у российских пациенток.

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