Clinical and demographic characteristics of patients with hormone-sensitive HER2-negative advanced breast cancer receiving ribociclib in combination with endocrine therapy or combination chemotherapy in routine clinical practice in the Russian Federation: interim results of the ValerEE study

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  • Authors: Zhukova L.G.1, Artamonova E.V.2,3,4, Vladimirova L.Y.5, Vinogradova T.V.6, Voronkova L.M.7, Zhikhorev R.S.8, Leushina N.V.9, Mironov O.V.10, Reznikov V.А.11, Semenov E.V.12,13
  • Affiliations:
    1. A.S. Loginov Moscow Clinical Scientific Center, Moscow Healthcare Department
    2. N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
    3. N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia
    4. M.F. Vladimirsky Moscow Regional Research and Clinical Institute
    5. Rostov Research Institute of Oncology, Ministry of Health of Russia
    6. Sverdlovsk Regional Oncology Dispensary
    7. Republican Oncology Dispensary, Ministry of Health of the Republic of North Ossetia – Alania
    8. Moscow City Oncology Hospital No. 62, Moscow Healthcare Department
    9. S.G. Primushko Republican Clinical Oncology Dispensary, Ministry of Health of the Udmurt Republic
    10. Tambov Regional Clinical Oncology Dispensary
    11. Novartis Pharma LLC
    12. V.F. Voyno-Yasenetskiy Krasnoyarsk State Medical University, Ministry of Health of Russia
    13. A.I. Kryzhanovskiy Krasnoyarsk Regional Clinical Oncology Dispensary
  • Issue: Vol 21, No 3 (2025)
  • Pages: 33-49
  • Section: MAMMOLOGY. ORIGINAL REPORTS
  • Published: 21.11.2025
  • URL: https://ojrs.abvpress.ru/ojrs/article/view/1404
  • DOI: https://doi.org/10.17650/1994-4098-2025-21-3-33-49
  • ID: 1404

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Abstract

In this article, we report the interim results of a prospective non-interventional ValerEE study analyzing the efficacy and safety of ribociclib therapy in combination with endocrine therapy compared to other combination chemotherapy regimens in the first-line treatment of patients with hormone-sensitive HER2-negative advanced breast cancer in routine clinical practice in Russia. We analyzed the data of 188 patients, of whom 146 patients received ribociclib in combination with endocrine therapy, while 27 patients received other combination chemotherapy. Fifteen patients were excluded from the analysis as they did not meet the inclusion criteria (received monochemotherapy). The majority of participants were women (99.4 %) with a mean age of 59.1 years; most of them (76.9 %) reached menopause. Mastectomy with lymphadenectomy were the most common surgeries (47.4 % of cases). Ductal cancer was diagnosed in 83.2 % of patients. Expression of estrogen and progesterone receptors was detected in 100 % and 89.6 % of participants, respectively. Metastases were primarily located in the bones (60.7 %), lungs (53.8 %) and liver (50.3 %). Anastrozole was the most common endocrine agent used in combination with ribociclib (65.8 %); paclitaxel plus carboplatin were the most common (33.3 %) combination chemotherapy. The ratio of therapeutic options observed in this study reflects current clinical recommendations and routine clinical practice in the Russian Federation. Patient groups were well balanced with no significant differences between them, which will ensure accurate assessment of the effectiveness of different therapeutic regimens later.

About the authors

L. G. Zhukova

A.S. Loginov Moscow Clinical Scientific Center, Moscow Healthcare Department

Author for correspondence.
Email: zhukova.lyudmila008@gmail.com
ORCID iD: 0000-0003-4848-6938

Lyudmila Grigoryevna Zhukova 

86 Shosse Enthuziastov, Moscow 111123

Russian Federation

E. V. Artamonova

N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia; N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; M.F. Vladimirsky Moscow Regional Research and Clinical Institute

ORCID iD: 0000-0001-7728-9533

23 Kashirskoe Shosse, Moscow 115522

1 Ostrovityanova St., Moscow 117997

61 / 2 Schepkina St., Moscow 129110

Russian Federation

L. Yu. Vladimirova

Rostov Research Institute of Oncology, Ministry of Health of Russia

ORCID iD: 0000-0002-4822-5044

63 14-ya Liniya St., Rostov-on-Don 344037

Russian Federation

T. V. Vinogradova

Sverdlovsk Regional Oncology Dispensary

29 Soboleva St., Ekaterinburg 620036

Russian Federation

L. M. Voronkova

Republican Oncology Dispensary, Ministry of Health of the Republic of North Ossetia – Alania

77A Markusa St.,  Vladikavkaz 362002

Russian Federation

R. S. Zhikhorev

Moscow City Oncology Hospital No. 62, Moscow Healthcare Department

ORCID iD: 0000-0003-2281-7380

6 Staropetrovskiy Proezd, Moscow 125130

Russian Federation

N. V. Leushina

S.G. Primushko Republican Clinical Oncology Dispensary, Ministry of Health of the Udmurt Republic

102 Lenina St.,  Izhevsk 426009

Russian Federation

O. V. Mironov

Tambov Regional Clinical Oncology Dispensary

29B Moskovskaya St., Tambov 392000

Russian Federation

V. А. Reznikov

Novartis Pharma LLC

ORCID iD: 0009-0009-6413-3244

70 Leningradskiy Prospekt, Moscow 125315

Russian Federation

E. V. Semenov

V.F. Voyno-Yasenetskiy Krasnoyarsk State Medical University, Ministry of Health of Russia; A.I. Kryzhanovskiy Krasnoyarsk Regional Clinical Oncology Dispensary

ORCID iD: 0000-0002-4849-1940

1 Partizana Zheleznyaka St.,  Krasnoyarsk 660022

16 1-ya Smolenskaya St., Krasnoyarsk 660133

Russian Federation

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