The dynamics of adjuvant therapy selection for HER2-positive breast cancer in real clinical practice: the third consecutive analysis of physicians’ preferences in the Russian Federation
https://doi.org/10.33667/2078-5631-2026-8-54-62
Abstract
Neoadjuvant chemotargeted therapy for HER2 positive breast cancer, incorporating two monoclonal antibodies (trastuzumab and pertuzumab), enables achieving the maximum rate of pathologic complete responses (pCR), which significantly improves the prognosis and long term treatment outcomes. According to our data, even in a patient population “enriched” with locally advanced inoperable tumours (T4 or N 2–3), the use of the TCHP regimen ensures a pCR rate exceeding 60 %. Based on the findings of the phase 3 randomized clinical trial KATHERINE, in cases where residual tumour of any size is detected (RCB I, II, and III), administration of post neoadjuvant therapy with trastuzumab emtansine (T-DM1) significantly improves survival. However, in the Russian Federation, the indication for adjuvant therapy with T-DM1 is limited to RCB II and III only. In contrast, for RCB I (minimal residual tumour), adjuvant therapy with trastuzumab – which is part of the NACHTT regimen – is recommended. To assess real-world clinical practice in the Russian Federation and identify trends in physicians’ preferences for adjuvant targeted therapy, the third consecutive survey study “Therapy for HER2-Positive Breast Cancer” (conducted in 2021, 2023, and 2025) was carried out. The survey included questions addressing the post-neoadjuvant phase. Fifty oncology specialists from six regions of the country (Central, Northwestern, Siberia/Far East, Southern, Ural, and Volga regions) participated in the survey. These specialists either independently or as part of a tumor board prescribe treatment for patients diagnosed with HER2-positive breast cancer. This publication presents the results of assessing specialists’ preferences in prescribing adjuvant and post-neoadjuvant therapy. In 2025, neoadjuvant chemotargeted therapy (NACTT) was prescribed/planned for only 75 % of patients with early-stage (M0) HER2+ BC, which is slightly lower compared to previous surveys. According to the respondents, the pCR rate after NACHTT was 49 %; RCB I was reported in another 23 % of cases, while pathological response assessment was not performed in 2 % of cases. Thus, the proportion of patients with moderate to severe residual tumour (RCB II–III) after NACHTT significantly decreased in 2025, reaching only 26 %, compared to 35 % in 2023. The vast majority of patients with RCB II–III (88 %) received post-neoadjuvant T-DM1 adjuvant therapy in 2025, compared to 68 % in 2023 and 24 % in 2021. Additionally, T-DM1 was occasionally prescribed in the Russian clinical practice for RCB I cases as well. Analyzing adherence to the post-neoadjuvant T-DM1 therapy plan, high patient compliance and good drug tolerability were noted: 82.2 % completed the full course of 14 cycles, while another 17.4 % received 7 to 13 cycles. Overall, when selecting a drug treatment regimen for early operable and locally advanced inoperable HER2-positive BC in the Russian Federation, the priority is given to therapy efficacy and safety. The significance of the issue of drug availability is steadily decreasing.
About the Authors
E. V. ArtamonovaRussian Federation
Artamonova Elena V., Dr Med Sci (habil.), head of Dept of Medicinal Treatment Methods No. 1; professor at Dept; head of Dept
Moscow
E. V. Lubennikova
Russian Federation
Lubennikova Elena V., PhD Med Sci, senior researcher at Dept of Medicinal Treatment Methods No. 1
Moscow
References
1. International Agency for Research on Cancer. Global Cancer Observatory: Cancer Today. URL: https://gco.iarc.who.int/today/en/dataviz/pie?mode=cancer&group_populations=1&types=1 (дата обращения: 01.04.2026).
2. International Agency for Research on Cancer. Economic Burden of Cancer: Productivity Loss. URL: https://gco.iarc.who.int/economics/productivity_loss/en/dataviz/maps?cancers=20&key=ypllrate (дата обращения: 01.04.2026).
3. Malignant neoplasms in Russia in 2024 (incidence) / Edited by A. D. Kaprin, V. V. Starinsky, A. O. Shakhzadova, I. Yu. Zolotarev. – M.: FGBU «P. A. Herzen Moscow Oncology Research Institute» of the Ministry of Health of the Russian Federation, 2025. 178 p. м
4. Grinda T, et al. Evolution of overall survival and receipt of new therapies by subtype among 20 446 metastatic breast cancer patients in the 2008–2017 ESME cohort. ESMO Open. 2021; 6 (3): 100114. DOI: 10.1016/j.esmoop.2021.100114
5. Ibragimova KhIE, Geurts SME, Croes S, et al. Survival before and after the introduction of pertuzumab and T DM1 in HER2 positive advanced breast cancer: a study of the SONABRE Registry. Breast Cancer Res Treat. 2021: 1–11. DOI: 10.1007/s10549‑021‑06347‑5
6. PiccartGebhart MJ, Procter M, LeylandJones B, et al. Trastuzumab after adjuvant chemotherapy in HER2positive breast cancer. N Engl J Med. 2005; 353 (16): 1659–1672. DOI: 10.1056/NEJMoa052306
7. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2positive breast cancer. N Engl J Med. 2005; 353 (16): 1673–1684. DOI: 10.1056/NEJMoa052122
8. Conte P, Frassoldati A, Bisagni G, et al. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized ShortHER study. Ann Oncol. 2018; 29 (12): 2328–2333. DOI: 10.1093/annonc/mdy414
9. Joensuu H, Fraser J, Wildiers H, et al. Effect of adjuvant trastuzumab for a duration of 9 weeks vs 1 year with concomitant chemotherapy for early human epidermal growth factor receptor 2positive breast cancer: the SOLD randomized clinical trial. JAMA Oncol. 2018; 4 (9): 1199–1206. DOI: 10.1001/jamaoncol.2018.138
10. Mavroudis D, Saloustros E, Malamos N, et al; Breast Cancer Investigators of Hellenic Oncology Research Group (HORG), Athens, Greece. Six versus 12 months of adjuvant trastuzumab in combination with dosedense chemotherapy for women with HER2positive breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG). Ann Oncol. 2015; 26 (7): 1333–1340. DOI: 10.1093/annonc/mdv213
11. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Trastuzumab for earlystage, HER2positive breast cancer: a metaanalysis of 13 864 women in seven randomised trials. Lancet Oncol. 2021; 22 (8): 1139–1150. DOI: 10.1016/S1470–2045(21)00288‑6
12. Pivot X, Romieu G, Debled M, et al; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, openlabel, phase 3 randomised trial. Lancet. 2019; 393 (10191): 2591–2598. DOI: 10.1016/S0140–6736(19)30653‑1
13. Niraula S, Gyawali B. Optimal duration of adjuvant trastuzumab in treatment of early breast cancer: a metaanalysis of randomized controlled trials. Breast Cancer Res Treat. 2019; 173 (1): 103–109. DOI: 10.1007/s10549‑018‑4967‑8
14. Earl HM, Hiller L, Vallier AL, et al; PERSEPHONE Steering Committee and Trial Investigators. 6 versus 12 months of adjuvant trastuzumab for HER2positive early breast cancer (PERSEPHONE): 4year diseasefree survival results of a randomized phase 3 noninferiority trial. Lancet. 2019; 393 (10191): 2599–2612. DOI: 10.1016/S0140–6736(19)30650‑6
15. Earl HM, Hiller L, Dunn JA, et al. Individual patient data metaanalysis of 5 noninferiority RCTs of reduced duration single agent adjuvant trastuzumab in the treatment of HER2 positive early breast cancer. Ann Oncol. 2021; 32 (Suppl 5): S 1283–S 1346. DOI: 10.1016/j.annonc.2021.08.2083
16. Piccart M, Procter M, Fumagalli D, et al; APHINITY steering committee and investigators. Adjuvant pertuzumab and trastuzumab in early HER2positive breast cancer in the APHINITY trial: 6 years’ followup. J Clin Oncol. 2021; 39 (4): JCO2001204. DOI: 10.1200/JCO.20.01204
17. Loibl S, Jassem J, Sonnenblick A, et al. Adjuvant pertuzumab and trastuzumab in patients with early HER2positive breast cancer in APHINITY: 8.4 years’ followup. Ann Oncol. 2022; 33 (9): 986–987. DOI: 10.1016/j.annonc.2022.06.009
18. Swain SM, Baselga J, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel in HER-2positive metastatic breast cancer. N Engl J Med. 2015; 372 (8): 724–734. DOI: 10.1056/NEJMoa1413513
19. Clinical guidelines "Breast Cancer", 2021. Clinical guidelines index of the Ministry of Health. URL: https://cr.minzdrav.gov.ru/preview-cr/379_4 (accessed: 01.04.2026) (In Russ.).
20. Gnant M, Harbeck N, Thomssen C. St. Gallen/Vienna 2017: a brief summary of the consensus discussion about escalation and deescalation of primary breast cancer treatment. Breast Care. 2017; 12 (2): 101–106. DOI: 10.1159/000475698
21. Zhang J, Yu Y, Lin Y, et al. Efficacy and safety of neoadjuvant therapy for HER2-positive early breast cancer: a network meta-analysis. Ther Adv Med Oncol. 2021 Apr 3; 13: 17588359211006948. DOI: 10.1177/17588359211006948
22. Gennari, A., André, F., Barrios, C. H., et al. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Annals of oncology, 2021; 32 (12): 1475–1495. https://doi.org/10.1016/j.annonc.2021.09.019
23. Cortazar P., Zhang L., Untch M., et al. Pathological complete response and long-term clinical benefit in breast cancer: The CTNeoBC pooled analysis. Lancet. 2014; 384 (9938): 164–172. https://doi.org/10.1016/S0140–6736(13)62422‑8
24. Spring L. M., Fell G., Arfe A., et al. Pathologic Complete Response after Neoadjuvant Chemotherapy and Impact on Breast Cancer Recurrence and Survival: A Comprehensive Meta-analysis. Clin Cancer Res. 2020; 26 (12):2838–2848. https://doi.org/10.1158/1078–0432.CCR‑19–3492.
25. Jackisch C., Cortazar P., Geyer Jr C. E., Gianni L., Gligorov J., Machackova Z. et al. Risk-based decision-making in the treatment of HER2-positive early breast cancer: Recommendations based on the current state of knowledge. Cancer Treat Rev. 2021; 99: 102229. https://doi.org/10.1016/j.ctrv.2021.102229.
26. A. R. Minnibaeva, E. V. Artamonova, Ya. A. Zhulikov, M. V. Khoroshilov, E. I. Kovalenko. TCHP regimen in neoadjuvant therapy of primary resectable and locally advanced unresectable HER2-positive breast cancer. Medical alphabet 2023 (36) – series Diagnostics and oncotherapy 2023, No. 4 –pp. 24–29. (In Russ.). https://doi.org/10.33667/2078‑5631‑2023‑36‑24‑29
27. Kovalenko E. I., Zhulikov Ya.A., Artamonova E. V., Khoroshilov M. V., Petrovsky A. V., Denchik D. A., Druzhinina D. I., Vorotnikov I. K. Dose-dense neoadjuvant chemotherapy of primary resectable and locally advanced inoperable triple-negative breast cancer: first results of a prospective single-center study. Medical Alphabet
28. , No. 10. Diagnostics and Oncotherapy (1), 11–17. (In Russ.). DOI: 10.33667/2078‑5631‑2023‑10‑11‑17
29. Von Minckwitz, G., Huang, C. S., Mano, M. S., et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. New England Journal of Medicine, 2019; 380 (7): 617–628. DOI: 10.1056/NEJMoa1814017
30. Cheng, H. H., Giri, V. N., Goggins, M., Yurgelun, M. B., Karlan, B. Y., Norquist, B. S., …& Dwyer, M. (2026). NCCN Guidelines® Insights: Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate, Version 2.2026: Featured Updates to the NCCN Guidelines. Journal of the National Comprehensive Cancer Network, 24 (2), 2–10.
31. Gennari, A., André, F., Barrios, C. H., Cortes, J., de Azambuja, E., DeMichele, A., … & ESMO Guidelines Committee. (2021). ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Annals of oncology, 32 (12), 1475–1495.
32. Tyulyandin S. A., Artamonova E. V., Zhigulev A. N., Zhukova L. G., Karabina E. V., Koroleva I. A., Parokonnaya A. A., Semiglazova T. Yu., Stenina M. B., Frolova M. A. Breast cancer. RUSSCO practical recommendations, part 1.2. Malignant neoplasms 2025; 15 (3 s2): 35–83. (In Russ.).
33. https://doi.org/10.33667/2078‑5631‑2023‑27‑7‑12
34. Artamonova E. V., Lubennikova E. V. Optimal choice of neoadjuvant therapy for Her2-positive breast cancer. Analysis of physicians’ preferences in the Russian Federation. – Medical alphabet 2023 (27) – series Diagnostics and oncotherapy 2023, No. 3, pp. 7–12. (In Russ.). https://doi.org/10.33667/2078‑5631‑2023‑27‑7‑12
35. Lubennikova E. V., Artamonova E. V. The choice of adjuvant therapy for HER2-positive breast cancer in real-life clinical practice: an analysis of physicians’ preferences in the Russian Federation. – Medical Alphabet 2024 (N 7) – Diagnostics and Oncotherapy 2024 series, No. 1 – pp. 7–12. (In Russ.). https://doi.org/10.33667/2078‑5631‑2024‑7‑7‑12
36. Loibl S, Mano M, Untch M, et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. Presented at: 2023 San Antonio Breast Cancer Symposium; December 5–9, 2023; San Antonio, TX. Abstract GS 03–12. https://medically.roche.com/content/dam/pdmahub/restricted/oncology/sabcs-2023/SABCS-2023-presentation-loibl-phaseiii-study-of-adjuvant-ado.pdf
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For citations:
Artamonova E.V., Lubennikova E.V. The dynamics of adjuvant therapy selection for HER2-positive breast cancer in real clinical practice: the third consecutive analysis of physicians’ preferences in the Russian Federation. Medical alphabet. 2026;(8):54-62. (In Russ.) https://doi.org/10.33667/2078-5631-2026-8-54-62
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