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По следам ASCO-2025: топ исследований, которые изменят стратегию лечения распространенного HR+ и HER2+ рака молочной железы
По следам ASCO-2025: топ исследований, которые изменят стратегию лечения распространенного HR+ и HER2+ рака молочной железы
Колядина И.В., Поддубная И.В. По следам ASCO-2025: топ исследований, которые изменят стратегию лечения распространенного HR+ и HER2+ рака молочной железы. Современная Онкология. 2025;27(3):187–197. DOI: 10.26442/18151434.2025.3.203471
© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.
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Аннотация
В настоящем обзоре отражены 6 наиболее значимых клинических исследований по лечению распространенного гормонозависимого и HER2-положительного (HER2+) рака молочной железы (РМЖ), представленных на конгрессе ASCO в 2025 г. Среди новых данных по преодолению гормонорезистентности заслуживают особого внимания оценка общей выживаемости у больных с ранними рецидивами с мутацией гена PIK3CA в исследовании INAVO120, идея о молекулярно-навигационной стратегии переключения эндокринотерапии при появлении мутации гена ESR1 в рандомизированном клиническом исследовании SERENA-6, а также биомаркерный анализ эффективности лечения трастузумабом дерукстеканом при распространенном РМЖ с экспрессией HER2-low/ultralow в рандомизированном клиническом исследовании DESTINY-Breast06. Для лечения пациентов с распространенным HER2+ РМЖ будут обсуждены анализ эффективности и безопасности комбинации трастузумаба дерукстекана с пертузумабом в 1-й линии лечения, возможность повторного назначения трастузумаба дерукстекана при развившемся интерстициальном пневмоните, а также новое направление в лечении люминального HER2+ варианта заболевания – комбинация ингибиторов CDK4/6 с анти-HER2-терапией.
Ключевые слова: новости ASCO-2025, гормонозависимый метастатический рак молочной железы, HER2+ метастатический рак молочной железы, преодоление эндокринорезистентности, ранние рецидивы с мутацией гена PIK3CA, мутация гена ESR1, экспрессия HER2-low/ultralow, трастузумаб дерукстекан, T-DXd, повторное назначение трастузумаба дерукстекана при интерстициальном пневмоните, ингибиторы CDK4/6 с анти-HER2-терапией
Keywords: ASCO-2025 news, hormone-dependent metastatic breast cancer, HER2+ metastatic breast cancer, overcoming endocrine resistance, early relapses with PIK3CA gene mutation, ESR1 gene mutation, HER2-low/ultralow expression, trastuzumab deruxtecan, T-DXd, rechallenge T-DXd in case ofinterstitial pneumonitis, CDK4/6 inhibitors with anti-HER2 therapy
Ключевые слова: новости ASCO-2025, гормонозависимый метастатический рак молочной железы, HER2+ метастатический рак молочной железы, преодоление эндокринорезистентности, ранние рецидивы с мутацией гена PIK3CA, мутация гена ESR1, экспрессия HER2-low/ultralow, трастузумаб дерукстекан, T-DXd, повторное назначение трастузумаба дерукстекана при интерстициальном пневмоните, ингибиторы CDK4/6 с анти-HER2-терапией
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Keywords: ASCO-2025 news, hormone-dependent metastatic breast cancer, HER2+ metastatic breast cancer, overcoming endocrine resistance, early relapses with PIK3CA gene mutation, ESR1 gene mutation, HER2-low/ultralow expression, trastuzumab deruxtecan, T-DXd, rechallenge T-DXd in case ofinterstitial pneumonitis, CDK4/6 inhibitors with anti-HER2 therapy
Полный текст
Список литературы
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22. Тюляндин С.А., Артамонова Е.В., Жигулев А.Н., и др. Рак молочной железы. Практические рекомендации RUSSCO, часть 1.2. Злокачественные опухоли. 2024;14(3s2):32-81 [Tyulandin SA, Artamonova EV, Zhigulev AN, et al. Breast cancer. RUSSCO's Practical Recommendations, Part 1.2. Malignant Tumors. 2024;14(3s2):32-81 (in Russian)]. DOI:10.18027/2224-5057-2024-14-3s2-1.2-01
23. Tolaney SM, Jiang Z, Zhang Q, et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025, Abstract #LBA1008. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT493716. Accessed: 05.08.2025.
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related interstitial lung disease: A multi-institution cohort study. Rapid Oral Abstract Session, Abstract #1015. Available at: https://meetings.asco.org/abstracts-presentations/253149. Accessed: 05.08.2025.
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27. Rugo HS, Crossno CL, Gesthalter YB, et al. Real-world perspectives and practices for pneumonitis/interstitial lung disease associated with trastuzumab deruxtecan use in human epidermal growth factor receptor 2-expressing metastatic breast cancer. JCO Oncol Pract. 2023;19(8):539-46. DOI:10.1200/OP.22.00480
28. Natsuhara KH, Blum K, LeVee A, et al. Treatment rechallenge after trastuzumab-deruxtecan-related interstitial lung disease: A multi-institution cohort study. J Clin Oncol. 2025;43(Suppl. 16). DOI:10.1200/JCO.2025.43.16_suppl.1015
29. Tolaney SM, Goel S, Nadal J, et al. Overall survival and exploratory biomarker analyses of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus chemotherapy in HR+, HER2+ metastatic breast cancer patients. Clin Cancer Res. 2023;30(1):39-49. DOI:10.1158/1078-0432.CCR-23-1209
30. Loibl S, Metzger O, Mandrekar SJ, et al. PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib 1 Anti-HER2 therapy 1 endocrine therapy (ET) vs. anti-HER2 therapy 1 ET after induction treatment for hormone receptor positive (HR1)/HER2-positive metastatic breast cancer (MBC). Ann Oncol. 2018;29(Suppl. 8): viii121. DOI:10.1093/annonc/mdy272
2. Turner N, Mayer EL, Park YH, et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial. ASCO 2025, Abstract #LBA4. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT487304. Accessed: 05.08.2025.
3. Dent R, Curigliano G, Hu X, et al. Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/ultralow, hormone receptor-positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). ASCO 2025, Abstract #1013. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT501216. Accessed: 05.08.2025.
4. Dhillon P, et al. Real-word observational study of patients with endocrine-resistant, hormone HR+ HER2- negative metastatic breast cancer in the first-line setting: patient characreristics, PIK3CA munation prevalence, treatment, and clinical outcomes. SABCS 2024 (Poster P4-07-27).
5. Wang SF, Chou CY, Chao YW, et al. Impact of PIK3CA mutations on the clinical benefits of CDK 4/6 inhibitors in HR+/HER2- advanced breast cancer: An updated pairwise and network meta-analysis. J Cancer. 2025;16(10):3065-79. DOI:10.7150/jca.111362
6. Schagerholm C, Robertson S, Toosi H, et al. PIK3CA mutations in endocrine-resistant breast cancer. Sci Rep. 2024;14(1):12542. DOI:10.1038/s41598-024-62664-1
7. Cortés J, Im SA, Holgado E, et al. The next era of treatment for hormone receptor-positive, HER2-negative advanced breast cancer: Triplet combination-based endocrine therapies. Cancer Treat Rev. 2017;61:53-60. DOI:10.1016/j.ctrv.2017.09.011
8. Jhaveri KL, Im SA, Saura C, et al. Inavolisib or placebo in combination with palbociclib and fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer: Phase III INAVO120 primary analysis. SABCS 2023. Abstract GS03-13. Available at: https://medically.roche.com/content/dam/pdmahub/restricted/oncology/sabcs-2023/SABCS-2023-presentati.... Accessed: 05.01.2025.
9. Jhaveri KL, Im SA, Saura C, et al. Overall survival with inavolisib in PIK3CA-mutated advanced breast cancer. N Engl J Med. 2025;393(2):151-61. DOI:10.1056/NEJMoa2501796
10. Goetz MP, Hamilton EP, Campone M, et al. Landscape of baseline and acquired genomic alterations in circulating tumor DNA with abemaciclib alone or with endocrine therapy in advanced breast cancer. Clin Cancer Res. 2024;30(10):2233-44. DOI:10.1158/1078-0432.CCR-22-3573
11. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-7. DOI:10.1093/annonc/mdy155
12. Chaudhary N, Chibly AM, Collier A, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. NPJ Breast Cancer. 2024;10(1):15. DOI:10.1038/s41523-024-00617-7
13. Li X, Lu J, Zhang L, et al. Clinical implications of monitoring ESR1 mutations by circulating tumor DNA in estrogen receptor positive metastatic breast cancer: A pilot study. Transl Oncol. 2019;13(2):321-8. DOI:10.1016/j.tranon.2019.11.007
14. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-56. DOI:10.1200/JCO.22.00338
15. Bhave MA, Quintanilha JCF, Tukachinsky H, et al. Correction: Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice. Breast Cancer Res Treat. 2024;207(3):611-4. DOI:10.1007/s10549-024-07427-2
16. Oliveira M, Pominchuk D, Nowecki Z, et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol. 2024;25(11):1424-39. DOI:10.1016/S1470-2045(24)00387-5
17. Bardia A, Hu X, Dent R, et al.; DESTINY-Breast06 Trial Investigators. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med. 2024;391(22):2110-22. DOI:10.1056/NEJMoa2407086
18. Porter K, Rosenzweig MQ. Current and emerging therapies for HER2-positive women with metastatic breast cancer. J Adv Pract Oncol. 2017;8(2):164-8. PMID:29900024
19. Fenton MA, Tarantino P, Graff SL. Sequencing antibody drug conjugates in breast cancer: Exploring future roles. Curr Oncol. 2023;30(12):10211-23. DOI:10.3390/curroncol30120743
20. Premji SK, O'Sullivan CC. Standard-of-care treatment for HER2+ metastatic breast cancer and emerging therapeutic options. Breast Cancer (Auckl). 2024:18:11782234241234418. DOI:10.1177/11782234241234418
21. Grinda T, Antoine A, Jacot W, 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
22. Tyulandin SA, Artamonova EV, Zhigulev AN, et al. Breast cancer. RUSSCO's Practical Recommendations, Part 1.2. Malignant Tumors. 2024;14(3s2):32-81 (in Russian). DOI:10.18027/2224-5057-2024-14-3s2-1.2-01
23. Tolaney SM, Jiang Z, Zhang Q, et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025, Abstract #LBA1008. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT493716. Accessed: 05.08.2025.
24. Natsuhara KH, Blum K, LeVee A, et al. Treatment after trastuzumab-deruxtecan-
related interstitial lung disease: A multi-institution cohort study. Rapid Oral Abstract Session, Abstract #1015. Available at: https://meetings.asco.org/abstracts-presentations/253149. Accessed: 05.08.2025.
25. Sohn J, Lim S, Jeong JH, et al. Phase IB and II study of ribociclib with trastuzumab plus endocrine therapy in HR+/ HER2+ advanced breast cancer patients: Korean Cancer Study Group BR 18-2 MINI trial. Rapid Oral Abstract Session, Abstract #1016. Available at: https://meetings.asco.org/abstracts-presentations/244389. Accessed: 05.08.2025.
26. Rugo HS, Bianchini G, Cortes J, et al. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022;7(4):100553. DOI:10.1016/j.esmoop.2022.100553
27. Rugo HS, Crossno CL, Gesthalter YB, et al. Real-world perspectives and practices for pneumonitis/interstitial lung disease associated with trastuzumab deruxtecan use in human epidermal growth factor receptor 2-expressing metastatic breast cancer. JCO Oncol Pract. 2023;19(8):539-46. DOI:10.1200/OP.22.00480
28. Natsuhara KH, Blum K, LeVee A, et al. Treatment rechallenge after trastuzumab-deruxtecan-related interstitial lung disease: A multi-institution cohort study. J Clin Oncol. 2025;43(Suppl. 16). DOI:10.1200/JCO.2025.43.16_suppl.1015
29. Tolaney SM, Goel S, Nadal J, et al. Overall survival and exploratory biomarker analyses of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus chemotherapy in HR+, HER2+ metastatic breast cancer patients. Clin Cancer Res. 2023;30(1):39-49. DOI:10.1158/1078-0432.CCR-23-1209
30. Loibl S, Metzger O, Mandrekar SJ, et al. PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib 1 Anti-HER2 therapy 1 endocrine therapy (ET) vs. anti-HER2 therapy 1 ET after induction treatment for hormone receptor positive (HR1)/HER2-positive metastatic breast cancer (MBC). Ann Oncol. 2018;29(Suppl. 8): viii121. DOI:10.1093/annonc/mdy272
2. Turner N, Mayer EL, Park YH, et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial. ASCO 2025, Abstract #LBA4. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT487304. Accessed: 05.08.2025.
3. Dent R, Curigliano G, Hu X, et al. Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/ultralow, hormone receptor-positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). ASCO 2025, Abstract #1013. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT501216. Accessed: 05.08.2025.
4. Dhillon P, et al. Real-word observational study of patients with endocrine-resistant, hormone HR+ HER2- negative metastatic breast cancer in the first-line setting: patient characreristics, PIK3CA munation prevalence, treatment, and clinical outcomes. SABCS 2024 (Poster P4-07-27).
5. Wang SF, Chou CY, Chao YW, et al. Impact of PIK3CA mutations on the clinical benefits of CDK 4/6 inhibitors in HR+/HER2- advanced breast cancer: An updated pairwise and network meta-analysis. J Cancer. 2025;16(10):3065-79. DOI:10.7150/jca.111362
6. Schagerholm C, Robertson S, Toosi H, et al. PIK3CA mutations in endocrine-resistant breast cancer. Sci Rep. 2024;14(1):12542. DOI:10.1038/s41598-024-62664-1
7. Cortés J, Im SA, Holgado E, et al. The next era of treatment for hormone receptor-positive, HER2-negative advanced breast cancer: Triplet combination-based endocrine therapies. Cancer Treat Rev. 2017;61:53-60. DOI:10.1016/j.ctrv.2017.09.011
8. Jhaveri KL, Im SA, Saura C, et al. Inavolisib or placebo in combination with palbociclib and fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer: Phase III INAVO120 primary analysis. SABCS 2023. Abstract GS03-13. Available at: https://medically.roche.com/content/dam/pdmahub/restricted/oncology/sabcs-2023/SABCS-2023-presentati.... Accessed: 05.01.2025.
9. Jhaveri KL, Im SA, Saura C, et al. Overall survival with inavolisib in PIK3CA-mutated advanced breast cancer. N Engl J Med. 2025;393(2):151-61. DOI:10.1056/NEJMoa2501796
10. Goetz MP, Hamilton EP, Campone M, et al. Landscape of baseline and acquired genomic alterations in circulating tumor DNA with abemaciclib alone or with endocrine therapy in advanced breast cancer. Clin Cancer Res. 2024;30(10):2233-44. DOI:10.1158/1078-0432.CCR-22-3573
11. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-7. DOI:10.1093/annonc/mdy155
12. Chaudhary N, Chibly AM, Collier A, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. NPJ Breast Cancer. 2024;10(1):15. DOI:10.1038/s41523-024-00617-7
13. Li X, Lu J, Zhang L, et al. Clinical implications of monitoring ESR1 mutations by circulating tumor DNA in estrogen receptor positive metastatic breast cancer: A pilot study. Transl Oncol. 2019;13(2):321-8. DOI:10.1016/j.tranon.2019.11.007
14. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-56. DOI:10.1200/JCO.22.00338
15. Bhave MA, Quintanilha JCF, Tukachinsky H, et al. Correction: Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice. Breast Cancer Res Treat. 2024;207(3):611-4. DOI:10.1007/s10549-024-07427-2
16. Oliveira M, Pominchuk D, Nowecki Z, et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol. 2024;25(11):1424-39. DOI:10.1016/S1470-2045(24)00387-5
17. Bardia A, Hu X, Dent R, et al.; DESTINY-Breast06 Trial Investigators. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med. 2024;391(22):2110-22. DOI:10.1056/NEJMoa2407086
18. Porter K, Rosenzweig MQ. Current and emerging therapies for HER2-positive women with metastatic breast cancer. J Adv Pract Oncol. 2017;8(2):164-8. PMID:29900024
19. Fenton MA, Tarantino P, Graff SL. Sequencing antibody drug conjugates in breast cancer: Exploring future roles. Curr Oncol. 2023;30(12):10211-23. DOI:10.3390/curroncol30120743
20. Premji SK, O'Sullivan CC. Standard-of-care treatment for HER2+ metastatic breast cancer and emerging therapeutic options. Breast Cancer (Auckl). 2024:18:11782234241234418. DOI:10.1177/11782234241234418
21. Grinda T, Antoine A, Jacot W, 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
22. Тюляндин С.А., Артамонова Е.В., Жигулев А.Н., и др. Рак молочной железы. Практические рекомендации RUSSCO, часть 1.2. Злокачественные опухоли. 2024;14(3s2):32-81 [Tyulandin SA, Artamonova EV, Zhigulev AN, et al. Breast cancer. RUSSCO's Practical Recommendations, Part 1.2. Malignant Tumors. 2024;14(3s2):32-81 (in Russian)]. DOI:10.18027/2224-5057-2024-14-3s2-1.2-01
23. Tolaney SM, Jiang Z, Zhang Q, et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025, Abstract #LBA1008. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT493716. Accessed: 05.08.2025.
24. Natsuhara KH, Blum K, LeVee A, et al. Treatment after trastuzumab-deruxtecan-
related interstitial lung disease: A multi-institution cohort study. Rapid Oral Abstract Session, Abstract #1015. Available at: https://meetings.asco.org/abstracts-presentations/253149. Accessed: 05.08.2025.
25. Sohn J, Lim S, Jeong JH, et al. Phase IB and II study of ribociclib with trastuzumab plus endocrine therapy in HR+/ HER2+ advanced breast cancer patients: Korean Cancer Study Group BR 18-2 MINI trial. Rapid Oral Abstract Session, Abstract #1016. Available at: https://meetings.asco.org/abstracts-presentations/244389. Accessed: 05.08.2025.
26. Rugo HS, Bianchini G, Cortes J, et al. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022;7(4):100553. DOI:10.1016/j.esmoop.2022.100553
27. Rugo HS, Crossno CL, Gesthalter YB, et al. Real-world perspectives and practices for pneumonitis/interstitial lung disease associated with trastuzumab deruxtecan use in human epidermal growth factor receptor 2-expressing metastatic breast cancer. JCO Oncol Pract. 2023;19(8):539-46. DOI:10.1200/OP.22.00480
28. Natsuhara KH, Blum K, LeVee A, et al. Treatment rechallenge after trastuzumab-deruxtecan-related interstitial lung disease: A multi-institution cohort study. J Clin Oncol. 2025;43(Suppl. 16). DOI:10.1200/JCO.2025.43.16_suppl.1015
29. Tolaney SM, Goel S, Nadal J, et al. Overall survival and exploratory biomarker analyses of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus chemotherapy in HR+, HER2+ metastatic breast cancer patients. Clin Cancer Res. 2023;30(1):39-49. DOI:10.1158/1078-0432.CCR-23-1209
30. Loibl S, Metzger O, Mandrekar SJ, et al. PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib 1 Anti-HER2 therapy 1 endocrine therapy (ET) vs. anti-HER2 therapy 1 ET after induction treatment for hormone receptor positive (HR1)/HER2-positive metastatic breast cancer (MBC). Ann Oncol. 2018;29(Suppl. 8): viii121. DOI:10.1093/annonc/mdy272
________________________________________________
2. Turner N, Mayer EL, Park YH, et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial. ASCO 2025, Abstract #LBA4. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT487304. Accessed: 05.08.2025.
3. Dent R, Curigliano G, Hu X, et al. Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/ultralow, hormone receptor-positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). ASCO 2025, Abstract #1013. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT501216. Accessed: 05.08.2025.
4. Dhillon P, et al. Real-word observational study of patients with endocrine-resistant, hormone HR+ HER2- negative metastatic breast cancer in the first-line setting: patient characreristics, PIK3CA munation prevalence, treatment, and clinical outcomes. SABCS 2024 (Poster P4-07-27).
5. Wang SF, Chou CY, Chao YW, et al. Impact of PIK3CA mutations on the clinical benefits of CDK 4/6 inhibitors in HR+/HER2- advanced breast cancer: An updated pairwise and network meta-analysis. J Cancer. 2025;16(10):3065-79. DOI:10.7150/jca.111362
6. Schagerholm C, Robertson S, Toosi H, et al. PIK3CA mutations in endocrine-resistant breast cancer. Sci Rep. 2024;14(1):12542. DOI:10.1038/s41598-024-62664-1
7. Cortés J, Im SA, Holgado E, et al. The next era of treatment for hormone receptor-positive, HER2-negative advanced breast cancer: Triplet combination-based endocrine therapies. Cancer Treat Rev. 2017;61:53-60. DOI:10.1016/j.ctrv.2017.09.011
8. Jhaveri KL, Im SA, Saura C, et al. Inavolisib or placebo in combination with palbociclib and fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer: Phase III INAVO120 primary analysis. SABCS 2023. Abstract GS03-13. Available at: https://medically.roche.com/content/dam/pdmahub/restricted/oncology/sabcs-2023/SABCS-2023-presentati.... Accessed: 05.01.2025.
9. Jhaveri KL, Im SA, Saura C, et al. Overall survival with inavolisib in PIK3CA-mutated advanced breast cancer. N Engl J Med. 2025;393(2):151-61. DOI:10.1056/NEJMoa2501796
10. Goetz MP, Hamilton EP, Campone M, et al. Landscape of baseline and acquired genomic alterations in circulating tumor DNA with abemaciclib alone or with endocrine therapy in advanced breast cancer. Clin Cancer Res. 2024;30(10):2233-44. DOI:10.1158/1078-0432.CCR-22-3573
11. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-7. DOI:10.1093/annonc/mdy155
12. Chaudhary N, Chibly AM, Collier A, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. NPJ Breast Cancer. 2024;10(1):15. DOI:10.1038/s41523-024-00617-7
13. Li X, Lu J, Zhang L, et al. Clinical implications of monitoring ESR1 mutations by circulating tumor DNA in estrogen receptor positive metastatic breast cancer: A pilot study. Transl Oncol. 2019;13(2):321-8. DOI:10.1016/j.tranon.2019.11.007
14. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-56. DOI:10.1200/JCO.22.00338
15. Bhave MA, Quintanilha JCF, Tukachinsky H, et al. Correction: Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice. Breast Cancer Res Treat. 2024;207(3):611-4. DOI:10.1007/s10549-024-07427-2
16. Oliveira M, Pominchuk D, Nowecki Z, et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol. 2024;25(11):1424-39. DOI:10.1016/S1470-2045(24)00387-5
17. Bardia A, Hu X, Dent R, et al.; DESTINY-Breast06 Trial Investigators. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med. 2024;391(22):2110-22. DOI:10.1056/NEJMoa2407086
18. Porter K, Rosenzweig MQ. Current and emerging therapies for HER2-positive women with metastatic breast cancer. J Adv Pract Oncol. 2017;8(2):164-8. PMID:29900024
19. Fenton MA, Tarantino P, Graff SL. Sequencing antibody drug conjugates in breast cancer: Exploring future roles. Curr Oncol. 2023;30(12):10211-23. DOI:10.3390/curroncol30120743
20. Premji SK, O'Sullivan CC. Standard-of-care treatment for HER2+ metastatic breast cancer and emerging therapeutic options. Breast Cancer (Auckl). 2024:18:11782234241234418. DOI:10.1177/11782234241234418
21. Grinda T, Antoine A, Jacot W, 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
22. Tyulandin SA, Artamonova EV, Zhigulev AN, et al. Breast cancer. RUSSCO's Practical Recommendations, Part 1.2. Malignant Tumors. 2024;14(3s2):32-81 (in Russian). DOI:10.18027/2224-5057-2024-14-3s2-1.2-01
23. Tolaney SM, Jiang Z, Zhang Q, et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025, Abstract #LBA1008. Available at: https://www.asco.org/abstracts-presentations/ABSTRACT493716. Accessed: 05.08.2025.
24. Natsuhara KH, Blum K, LeVee A, et al. Treatment after trastuzumab-deruxtecan-
related interstitial lung disease: A multi-institution cohort study. Rapid Oral Abstract Session, Abstract #1015. Available at: https://meetings.asco.org/abstracts-presentations/253149. Accessed: 05.08.2025.
25. Sohn J, Lim S, Jeong JH, et al. Phase IB and II study of ribociclib with trastuzumab plus endocrine therapy in HR+/ HER2+ advanced breast cancer patients: Korean Cancer Study Group BR 18-2 MINI trial. Rapid Oral Abstract Session, Abstract #1016. Available at: https://meetings.asco.org/abstracts-presentations/244389. Accessed: 05.08.2025.
26. Rugo HS, Bianchini G, Cortes J, et al. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022;7(4):100553. DOI:10.1016/j.esmoop.2022.100553
27. Rugo HS, Crossno CL, Gesthalter YB, et al. Real-world perspectives and practices for pneumonitis/interstitial lung disease associated with trastuzumab deruxtecan use in human epidermal growth factor receptor 2-expressing metastatic breast cancer. JCO Oncol Pract. 2023;19(8):539-46. DOI:10.1200/OP.22.00480
28. Natsuhara KH, Blum K, LeVee A, et al. Treatment rechallenge after trastuzumab-deruxtecan-related interstitial lung disease: A multi-institution cohort study. J Clin Oncol. 2025;43(Suppl. 16). DOI:10.1200/JCO.2025.43.16_suppl.1015
29. Tolaney SM, Goel S, Nadal J, et al. Overall survival and exploratory biomarker analyses of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus chemotherapy in HR+, HER2+ metastatic breast cancer patients. Clin Cancer Res. 2023;30(1):39-49. DOI:10.1158/1078-0432.CCR-23-1209
30. Loibl S, Metzger O, Mandrekar SJ, et al. PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib 1 Anti-HER2 therapy 1 endocrine therapy (ET) vs. anti-HER2 therapy 1 ET after induction treatment for hormone receptor positive (HR1)/HER2-positive metastatic breast cancer (MBC). Ann Oncol. 2018;29(Suppl. 8): viii121. DOI:10.1093/annonc/mdy272
Авторы
И.В. Колядина*1,2, И.В. Поддубная1
1ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
2ФГБУ «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии им. акад. В.И. Кулакова» Минздрава России, Москва, Россия
*irinakolyadina@yandex.ru
1Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
2Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia
*irinakolyadina@yandex.ru
1ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
2ФГБУ «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии им. акад. В.И. Кулакова» Минздрава России, Москва, Россия
*irinakolyadina@yandex.ru
________________________________________________
1Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
2Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia
*irinakolyadina@yandex.ru
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.
