Updates and interpretation of the 2025 CSCO guidelines for HER2-positive breast cancer_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

LI Fan ¹ ,  LI Feng ^2,3 ,  ZHANG Shaohua ¹

1. Department of Oncology, The Fifth Medical Center of Chinese People’s Liberation Army of China General Hospital, Beijing 100071, P. R. China;
2. Department of Oncology, The 941st Hospital of Joint Logistics Support Force of Chinese People’s Liberation Army of China, Xining 810000, P. R. China;
3. Department of General Surgery, The First Medical Center of Chinese People’s Liberation Army of China General Hospital, Beijing 100853, P. R. China;

Corresponding author：

LI Feng, Email: lifeng73666@163.com; ZHANG Shaohua, Email: zhangshaohua@csco.org.cn

Keywords：

breast cancer; guideline update; Chinese Society of Clinical Oncology; human epidermal growth factor receptor 2-positive

DOI：

10.7507/1007-9424.202508039

Video：

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In April 2025, the Breast Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO) formally issued the CSCO Guidelines for Breast Cancer Diagnosis and Treatment (2025 Edition). These guidelines, building upon the 2024 edition, adhere to a stringent update protocol that incorporates evidence-based medical research, drug accessibility, and expert consensus, thereby ensuring scientific rigor while improving clinical applicability. This article systematically examines the principal revisions pertaining to the diagnosis and treatment of human epidermal growth factor receptor 2-positive breast cancer in the latest edition of the guidelines. We provide a comprehensive analysis, integrating the most recent international evidence-based medical findings, with the objective of offering a standardized reference for clinical decision-making.

1.	中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会 (CSCO) 乳腺癌诊疗指南2025. 北京: 人民卫生出版社, 2025: 31-99.
2.	李健斌, 江泽飞. 乳腺癌临床研究年度进展2024. 中华医学杂志, 2025, 105(22): 1864-1868.
3.	Hurvitz SA, Martin M, Jung KH, et al. Neoadjuvant trastuzumab emtansine and pertuzumab in human epidermal growth factor receptor 2-positive breast cancer: three-year outcomes from the phase Ⅲ KRISTINE study. J Clin Oncol, 2019, 37(25): 2206-2216.
4.	van Ramshorst MS, van der Voort A, van Werkhoven ED, et al. Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol, 2018, 19(12): 1630-1640.
5.	Chen XC, Jiao DC, Qiao JH, et al. De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial. Lancet Oncol, 2025, 26(1): 27-36.
6.	Wu S, Bian L, Wang H, et al. De-escalation of neoadjuvant taxane and carboplatin therapy in HER2-positive breast cancer with dual HER2 blockade: a multicenter real-world experience in China. World J Surg Oncol, 2024, 22(1): 214. doi: 10.1186/s12957-024-03468-5.
7.	Huang L, Pang D, Yang H, et al. Neoadjuvant-adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase Ⅲ PEONY trial. Nat Commun, 2024, 15(1): 2153. doi: 10.1038/s41467-024-45591-7.
8.	Wang K, et al. De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): a multicentre, open-label, randomised, phase 3 trial. Chicago: 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, 2025. doi: org/10.1200/JCO.2025.43.17_suppl.LBA500.
9.	Wang F, Wang Y, Xiong B, et al. Neoadjuvant pyrotinib and trastuzumab in HER2-positive breast cancer with no early response (NeoPaTHer): efficacy, safety and biomarker analysis of a prospective, multicentre, response-adapted study. Signal Transduct Target Ther, 2025, 10(1): 45. doi: 10.1038/s41392-025-02138-6.
10.	Wu J, Jiang Z, Liu Z, et al. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med, 2022, 20(1): 498. doi: 10.1186/s12916-022-02708-3.
11.	Gianni L, Pienkowski T, Im YH, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol, 2016, 17(6): 791-800.
12.	Krop IE, Lin NU, Blackwell K, et al. Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA. Ann Oncol, 2015, 26(1): 113-119.
13.	Cortés J, Hurvitz SA, Im SA, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial. Nat Med, 2024, 30(8): 2208-2215.
14.	Yao H, Yan M, Tong Z, et al. Safety, efficacy, and pharmacokinetics of SHR-A1811, a human epidermal growth factor receptor 2-directed antibody-drug conjugate, in human epidermal growth factor receptor 2-expressing or mutated advanced solid tumors: a global phase Ⅰ trial. J Clin Oncol, 2024, 42(29): 3453-3465.
15.	Li JJ, Wang ZH, Chen L, et al. Efficacy and safety of neoadjuvant SHR-A1811 with or without pyrotinib in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase Ⅱ trial. Ann Oncol, 2025, 36(6): 651-659.
16.	Piccart M, Procter M, Fumagalli D, et al. Adjuvant pertuzumab and trastuzumab in early her2-positive breast cancer in the APHINITY trial: 6 years’ follow-up. J Clin Oncol, 2021, 39(13): 1448-1457.
17.	Jones SE, Collea R, Paul D, et al. Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: a single-group, open-label, phase 2 study. Lancet Oncol, 2013, 14(11): 1121-1128.
18.	Tolaney SM, Guo H, Pernas S, et al. Seven-year follow-up analysis of adjuvant paclitaxel and trastuzumab trial for node-negative, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol, 2019, 37(22): 1868-1875.
19.	冀辰辰, 李健斌, 江泽飞. HER-2阳性乳腺癌分层治疗新策略. 中国肿瘤临床, 2022, 49(22): 1147-1150.
20.	Swain SM, Miles D, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol, 2020, 21(4): 519-530.
21.	Ma F, Yan M, Li W, et al. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial. BMJ, 2023, 383: e076065. doi: 10.1136/bmj-2023-076065.
22.	Sara Tolaney, 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. J Clin Oncol, 2025(Suppl 17): abstr LBA1008.
23.	Yan M, Bian L, Hu X, et al. Pyrotinib plus capecitabine for human epidermal factor receptor 2-positive metastatic breast cancer after trastuzumab and taxanes (PHENIX): a randomized, double-blind, placebo-controlled phase 3 study. Transl Breast Cancer Res, 2020(1): 13.
24.	Xu B, Yan M, Ma F, et al. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol, 2021, 22(3): 351-360.
25.	中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会 (CSCO) 乳腺癌诊疗指南2024. 北京: 人民卫生出版社, 2024: 89-93.
26.	Cortés J, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med, 2022, 386(12): 1143-1154.
27.	Li F, Li J, Ji C, et al. Novel anti-HER2 ADCs vs dual anti-HER2 antibody for HER2-positive metastatic breast cancer failed to tyrosine kinase inhibitor. Oncologist, 2025, 30(1): oyae144. doi: 10.1093/oncolo/oyae144.
28.	Ji C, Li F, Yuan Y, et al. Novel anti-HER2 antibody-drug conjugates versus T-DM1 for HER2-positive metastatic breast cancer after tyrosine kinase inhibitors treatment. Oncologist, 2023, 28(10): e859-e866.

1. 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会 (CSCO) 乳腺癌诊疗指南2025. 北京: 人民卫生出版社, 2025: 31-99.
2. 李健斌, 江泽飞. 乳腺癌临床研究年度进展2024. 中华医学杂志, 2025, 105(22): 1864-1868.
3. Hurvitz SA, Martin M, Jung KH, et al. Neoadjuvant trastuzumab emtansine and pertuzumab in human epidermal growth factor receptor 2-positive breast cancer: three-year outcomes from the phase Ⅲ KRISTINE study. J Clin Oncol, 2019, 37(25): 2206-2216.
4. van Ramshorst MS, van der Voort A, van Werkhoven ED, et al. Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol, 2018, 19(12): 1630-1640.
5. Chen XC, Jiao DC, Qiao JH, et al. De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial. Lancet Oncol, 2025, 26(1): 27-36.
6. Wu S, Bian L, Wang H, et al. De-escalation of neoadjuvant taxane and carboplatin therapy in HER2-positive breast cancer with dual HER2 blockade: a multicenter real-world experience in China. World J Surg Oncol, 2024, 22(1): 214. doi: 10.1186/s12957-024-03468-5.
7. Huang L, Pang D, Yang H, et al. Neoadjuvant-adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase Ⅲ PEONY trial. Nat Commun, 2024, 15(1): 2153. doi: 10.1038/s41467-024-45591-7.
8. Wang K, et al. De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): a multicentre, open-label, randomised, phase 3 trial. Chicago: 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, 2025. doi: org/10.1200/JCO.2025.43.17_suppl.LBA500.
9. Wang F, Wang Y, Xiong B, et al. Neoadjuvant pyrotinib and trastuzumab in HER2-positive breast cancer with no early response (NeoPaTHer): efficacy, safety and biomarker analysis of a prospective, multicentre, response-adapted study. Signal Transduct Target Ther, 2025, 10(1): 45. doi: 10.1038/s41392-025-02138-6.
10. Wu J, Jiang Z, Liu Z, et al. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med, 2022, 20(1): 498. doi: 10.1186/s12916-022-02708-3.
11. Gianni L, Pienkowski T, Im YH, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol, 2016, 17(6): 791-800.
12. Krop IE, Lin NU, Blackwell K, et al. Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA. Ann Oncol, 2015, 26(1): 113-119.
13. Cortés J, Hurvitz SA, Im SA, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial. Nat Med, 2024, 30(8): 2208-2215.
14. Yao H, Yan M, Tong Z, et al. Safety, efficacy, and pharmacokinetics of SHR-A1811, a human epidermal growth factor receptor 2-directed antibody-drug conjugate, in human epidermal growth factor receptor 2-expressing or mutated advanced solid tumors: a global phase Ⅰ trial. J Clin Oncol, 2024, 42(29): 3453-3465.
15. Li JJ, Wang ZH, Chen L, et al. Efficacy and safety of neoadjuvant SHR-A1811 with or without pyrotinib in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase Ⅱ trial. Ann Oncol, 2025, 36(6): 651-659.
16. Piccart M, Procter M, Fumagalli D, et al. Adjuvant pertuzumab and trastuzumab in early her2-positive breast cancer in the APHINITY trial: 6 years’ follow-up. J Clin Oncol, 2021, 39(13): 1448-1457.
17. Jones SE, Collea R, Paul D, et al. Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: a single-group, open-label, phase 2 study. Lancet Oncol, 2013, 14(11): 1121-1128.
18. Tolaney SM, Guo H, Pernas S, et al. Seven-year follow-up analysis of adjuvant paclitaxel and trastuzumab trial for node-negative, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol, 2019, 37(22): 1868-1875.
19. 冀辰辰, 李健斌, 江泽飞. HER-2阳性乳腺癌分层治疗新策略. 中国肿瘤临床, 2022, 49(22): 1147-1150.
20. Swain SM, Miles D, Kim SB, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol, 2020, 21(4): 519-530.
21. Ma F, Yan M, Li W, et al. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial. BMJ, 2023, 383: e076065. doi: 10.1136/bmj-2023-076065.
22. Sara Tolaney, 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. J Clin Oncol, 2025(Suppl 17): abstr LBA1008.
23. Yan M, Bian L, Hu X, et al. Pyrotinib plus capecitabine for human epidermal factor receptor 2-positive metastatic breast cancer after trastuzumab and taxanes (PHENIX): a randomized, double-blind, placebo-controlled phase 3 study. Transl Breast Cancer Res, 2020(1): 13.
24. Xu B, Yan M, Ma F, et al. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol, 2021, 22(3): 351-360.
25. 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会 (CSCO) 乳腺癌诊疗指南2024. 北京: 人民卫生出版社, 2024: 89-93.
26. Cortés J, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med, 2022, 386(12): 1143-1154.
27. Li F, Li J, Ji C, et al. Novel anti-HER2 ADCs vs dual anti-HER2 antibody for HER2-positive metastatic breast cancer failed to tyrosine kinase inhibitor. Oncologist, 2025, 30(1): oyae144. doi: 10.1093/oncolo/oyae144.
28. Ji C, Li F, Yuan Y, et al. Novel anti-HER2 antibody-drug conjugates versus T-DM1 for HER2-positive metastatic breast cancer after tyrosine kinase inhibitors treatment. Oncologist, 2023, 28(10): e859-e866.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Latest ArticlesUpdates and interpretation of the 2025 CSCO guidelines for HER2-positive breast cancer

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