Progress in adjuvant treatment of hormone receptor-positive early breast cancer_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

CHEN Fei ¹ , ZHAO Shiwei ² ,  GE Rui ²

1. Department of General Surgery, Putuo People’s Hospital Affiliated to Tongji University, Shanghai 200333, P. R. China;
2. Department of General Surgery, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, P. R. China;

Corresponding?author：

GE Rui, Email: rickyge1979@163.com

Keywords：

hormone receptor-positive; early breast cancer; adjuvant therapy

DOI：

10.7507/1007-9424.202510035

Video：

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Adjuvant therapy for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer is shifting from experience-based practice to precision risk stratification. Multigene assays increasingly guide chemotherapy de-escalation, endocrine intensification and extension, and decisions on adjuvant radiotherapy. In high-risk populations, cyclin-dependent kinases 4/6 inhibitors (abemaciclib, ribociclib, dalpiciclib) have established an evidence base for adjuvant use. Key evidence from long-term ovarian function suppression follow-up in premenopausal women and extended therapy in postmenopausal women provides a crucial basis for tailored treatment duration. Neoadjuvant immunotherapy can improve the pathological complete response rate in a subset of biologically enriched HR-positive early breast cancer. The advancement of antibody-drug conjugates into earlier lines of therapy for the HER2-low expression population shows promising potential, possibly replacing some conventional chemotherapy.

Citation： CHEN Fei, ZHAO Shiwei, GE Rui. Progress in adjuvant treatment of hormone receptor-positive early breast cancer. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2025, 32(11): 1385-1389. doi: 10.7507/1007-9424.202510035 Copy

1.	Twelves C, Bartsch R, Ben-Baruch NE, et al. The place of chemotherapy in the evolving treatment landscape for patients with HR-positive/HER2-negative MBC. Clin Breast Cancer, 2022, 22(3): 223-234.
2.	Huppert LA, Gumusay O, Idossa D, et al. Systemic therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative early stage and metastatic breast cancer. CA Cancer J Clin, 2023, 73(5): 480-515.
3.	國家腫瘤質控中心乳腺癌專家委員會, 中國抗癌協會腫瘤藥物臨床研究專業委員會, 中國抗癌協會乳腺癌專業委員會. HR⁺/HER-2^–早期乳腺癌復發風險與臨床管理專家共識(2025版). 中華腫瘤雜志, 2025, 47(7): 599-616.
4.	Burstein HJ, Curigliano G, Thürlimann B, et al. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Ann Oncol, 2021, 32(10): 1216-1235.
5.	Loibl S, André F, Bachelot T, et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol, 2024, 35(2): 159-182.
6.	Andre F, Ismaila N, Allison KH, et al. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer: ASCO guideline update. J Clin Oncol, 2022, 40(16): 1816-1837.
7.	Klein E, Kiechle M, Josipovic A, et al. Long-term prospective outcome data using EndoPredict as risk stratification and chemotherapy decision biomarker in hormone receptor-positive, HER2-negative early breast cancer. Breast Cancer Res Treat, 2024, 207(1): 119-127.
8.	Mamounas EP, Bandos H, Rastogi P, et al. Breast cancer index and prediction of extended aromatase inhibitor therapy benefit in hormone receptor-positive breast cancer from the NRG Oncology/NSABP B-42 trial. Clin Cancer Res, 2024, 30(9): 1984-1991.
9.	Noordhoek I, Treuner K, Putter H, et al. Breast cancer index predicts extended endocrine benefit to individualize selection of patients with HR⁺ early-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res, 2021, 27(1): 311-319.
10.	Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med, 2018, 379(2): 111-121.
11.	Piccart M, van’t Veer LJ, Poncet C, et al. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol, 2021, 22(4): 476-488.
12.	Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med, 2021, 385(25): 2336-2347.
13.	Panet F, Papakonstantinou A, Borrell M, et al. Use of ctDNA in early breast cancer: analytical validity and clinical potential. NPJ Breast Cancer, 2024, 10(1): 50. doi: 10.1038/s41523-024-00653-3.
14.	Howard FM, Dolezal J, Kochanny S, et al. Integration of clinical features and deep learning on pathology for the prediction of breast cancer recurrence assays and risk of recurrence. NPJ Breast Cancer, 2023, 9(1): 25. doi: 10.1038/s41523-023-00530-5.
15.	Eisemann N, Bunk S, Mukama T, et al. Nationwide real-world implementation of AI for cancer detection in population-based mammography screening. Nat Med, 2025, 31(3): 917-924.
16.	Pan H, Gray R, Braybrooke J, et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med, 2017, 377(19): 1836-1846.
17.	Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR⁺, HER2^-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol, 2020, 38(34): 3987-3998.
18.	Fleming GF, Pagani O, Regan MM, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol, 2022, 33(6): 658. doi: 10.1016/j.annonc.2022.03.003.
19.	Rastogi P, O’Shaughnessy J, Martin M, et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol, 2024, 42(9): 987-993.
20.	Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase Ⅲ trial of adjuvant ribociclib+endocrine therapy versus endocrine therapy alone in patients with HR⁺/HER2^– early breast cancer. Ther Adv Med Oncol, 2023, 15: 17588359231178125. doi: 10.1177/17588359231178125.
21.	Fasching PA, Stroyakovskiy D, Yardley DA, et al. Ribociclib plus endocrine therapy in hormone receptor-positive/ERBB2-negative early breast cancer: 4-year outcomes from the NATALEE randomized clinical trial. JAMA Oncol, 2025 Sep 25: e253700. doi: 10.1001/jamaoncol.2025.3700.
22.	Hortobagyi GN, Lacko A, Sohn J, et al. A phase Ⅲ trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial. Ann Oncol, 2025, 36(2): 149-157.
23.	Pu D, Wu Y, Xu D, et al. The adverse events of CDK4/6 inhibitors for HR⁺/HER2^- breast cancer: an umbrella review of meta-analyses of randomized controlled trials. Front Pharmaco, 2024, 15: 1269922. doi: 10.3389/fphar.2024.1269922.
24.	Shao ZM, Hao JH, Wang S, et al. Dalpiciclib (Dalp) plus endocrine therapy (ET) as adjuvant treatment for HR⁺/HER2^– early breast cancer (BC): The randomized, phase 3, DAWNA-A trial. J Clin Oncol, 2025, 43(16_SUPPL): 515. doi: 10.1200/JCO.2025.43.16_suppl.515.
25.	Mamounas EP, Bandos H, Rastogi P, et al. Ten-year update: NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-42 randomized trial: extended letrozole therapy in early-stage breast cancer. J Natl Cancer Inst, 2023, 115(11): 1302-1309.
26.	Davies C, Pan H, Godwin J, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet, 2013, 381(9869): 805-816.
27.	Goss PE, Ingle JN, Pritchard KI, et al. Extending aromatase-inhibitor adjuvant therapy to 10 years. N Engl J Med, 2016, 375(3): 209-219.
28.	Gnant M, Fitzal F, Rinnerthaler G, et al. Duration of adjuvant aromatase-inhibitor therapy in postmenopausal breast cancer. N Engl J Med, 2021, 385(5): 395-405.
29.	Penault-Llorca F, Dalenc F, Chabaud S, et al. Prognostic value of EndoPredict test in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer screened for the randomized, double-blind, phase Ⅲ UNIRAD trial. ESMO Open, 2024, 9(5): 103443. doi: 10.1016/j.esmoop.2024.103443.
30.	Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Extending the duration of endocrine treatment for early breast cancer: patient-level meta-analysis of 12 randomised trials of aromatase inhibitors in 22 031 postmenopausal women already treated with at least 5 years of endocrine therapy. Lancet, 2025, 406(10503): 603-614.
31.	Francis PA, Fleming GF, Pagani O, et al. 15-year outcomes for women with premenopausal hormone receptor-positive early breast cancer (BC) in the SOFT and TEXT trials assessing benefits from adjuvant exemestane (E) + ovarian function suppression (OFS) or tamoxifen (T) + OFS. J Clin Oncol, 2025, 43(16_suppl): 505. doi: 10.1200/JCO.2025.43.16_suppl.505.
32.	Cardoso F, O’Shaughnessy J, Liu Z, et al. Pembrolizumab and chemotherapy in high-risk, early-stage, ER⁺/HER2^– breast cancer: a randomized phase 3 trial. Nat Med, 2025, 31(2): 442-448.
33.	Loi S, Salgado R, Curigliano G, et al. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nat Med, 2025, 31(2): 433-441.
34.	Cardoso F, Hirshfield KM, Kraynyak KA, et al. Immunotherapy for hormone receptor-positive HER2-negative breast cancer. NPJ Breast Cancer, 2024, 10(1): 104. doi: 10.1038/s41523-024-00704-9.
35.	Debien V, De Caluwé A, Wang X, et al. Immunotherapy in breast cancer: an overview of current strategies and perspectives. NPJ Breast Cancer, 2023, 9(1): 7. doi: 10.1038/s41523-023-00508-3.
36.	Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med, 2022, 387(1): 9-20.
37.	Bardia A, Hu X, Dent R, et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med, 2024, 391(22): 2110-2122.
38.	Tarantino P, Hamilton E, Tolaney SM, et al. HER2-low breast cancer: pathological and clinical landscape. J Clin Oncol, 2020, 38(17): 1951-1962.
39.	Bardia A, Hurvitz S, Press M F, et al. Abstract GS2-03: GS2-03 TRIO-US B-12 TALENT: neoadjuvant trastuzumab deruxtecan with or without anastrozole for HER2-low, HR⁺ early stage breast cancer. Cancer Res, 2023, 83(5_Supplement): GS2-3. doi: 10.1158/1538-7445.SABCS22-GS2-03.
40.	Esteva FJ, Katz E. Tailoring neoadjuvant therapy in human epidermal growth factor receptor 2-positive early breast cancer: recent advances and strategies. JCO Oncol Pract, 2024, 20(8): 1046-1054.
41.	Liu Z, Jiao D, Zhu J, et al. SHR-A1811 as neoadjuvant therapy for HR-positive, HER2-low breast cancer: a single-arm, phase Ⅱ clinical study. J Clin Oncol, 2025, 43(16_suppl): 594. doi: 10.1200/JCO.2025.43.16_suppl.594.

1. Twelves C, Bartsch R, Ben-Baruch NE, et al. The place of chemotherapy in the evolving treatment landscape for patients with HR-positive/HER2-negative MBC. Clin Breast Cancer, 2022, 22(3): 223-234.
2. Huppert LA, Gumusay O, Idossa D, et al. Systemic therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative early stage and metastatic breast cancer. CA Cancer J Clin, 2023, 73(5): 480-515.
3. 國家腫瘤質控中心乳腺癌專家委員會, 中國抗癌協會腫瘤藥物臨床研究專業委員會, 中國抗癌協會乳腺癌專業委員會. HR⁺/HER-2^–早期乳腺癌復發風險與臨床管理專家共識(2025版). 中華腫瘤雜志, 2025, 47(7): 599-616.
4. Burstein HJ, Curigliano G, Thürlimann B, et al. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Ann Oncol, 2021, 32(10): 1216-1235.
5. Loibl S, André F, Bachelot T, et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol, 2024, 35(2): 159-182.
6. Andre F, Ismaila N, Allison KH, et al. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer: ASCO guideline update. J Clin Oncol, 2022, 40(16): 1816-1837.
7. Klein E, Kiechle M, Josipovic A, et al. Long-term prospective outcome data using EndoPredict as risk stratification and chemotherapy decision biomarker in hormone receptor-positive, HER2-negative early breast cancer. Breast Cancer Res Treat, 2024, 207(1): 119-127.
8. Mamounas EP, Bandos H, Rastogi P, et al. Breast cancer index and prediction of extended aromatase inhibitor therapy benefit in hormone receptor-positive breast cancer from the NRG Oncology/NSABP B-42 trial. Clin Cancer Res, 2024, 30(9): 1984-1991.
9. Noordhoek I, Treuner K, Putter H, et al. Breast cancer index predicts extended endocrine benefit to individualize selection of patients with HR⁺ early-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res, 2021, 27(1): 311-319.
10. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med, 2018, 379(2): 111-121.
11. Piccart M, van’t Veer LJ, Poncet C, et al. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol, 2021, 22(4): 476-488.
12. Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med, 2021, 385(25): 2336-2347.
13. Panet F, Papakonstantinou A, Borrell M, et al. Use of ctDNA in early breast cancer: analytical validity and clinical potential. NPJ Breast Cancer, 2024, 10(1): 50. doi: 10.1038/s41523-024-00653-3.
14. Howard FM, Dolezal J, Kochanny S, et al. Integration of clinical features and deep learning on pathology for the prediction of breast cancer recurrence assays and risk of recurrence. NPJ Breast Cancer, 2023, 9(1): 25. doi: 10.1038/s41523-023-00530-5.
15. Eisemann N, Bunk S, Mukama T, et al. Nationwide real-world implementation of AI for cancer detection in population-based mammography screening. Nat Med, 2025, 31(3): 917-924.
16. Pan H, Gray R, Braybrooke J, et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med, 2017, 377(19): 1836-1846.
17. Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR⁺, HER2^-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol, 2020, 38(34): 3987-3998.
18. Fleming GF, Pagani O, Regan MM, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol, 2022, 33(6): 658. doi: 10.1016/j.annonc.2022.03.003.
19. Rastogi P, O’Shaughnessy J, Martin M, et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol, 2024, 42(9): 987-993.
20. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase Ⅲ trial of adjuvant ribociclib+endocrine therapy versus endocrine therapy alone in patients with HR⁺/HER2^– early breast cancer. Ther Adv Med Oncol, 2023, 15: 17588359231178125. doi: 10.1177/17588359231178125.
21. Fasching PA, Stroyakovskiy D, Yardley DA, et al. Ribociclib plus endocrine therapy in hormone receptor-positive/ERBB2-negative early breast cancer: 4-year outcomes from the NATALEE randomized clinical trial. JAMA Oncol, 2025 Sep 25: e253700. doi: 10.1001/jamaoncol.2025.3700.
22. Hortobagyi GN, Lacko A, Sohn J, et al. A phase Ⅲ trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial. Ann Oncol, 2025, 36(2): 149-157.
23. Pu D, Wu Y, Xu D, et al. The adverse events of CDK4/6 inhibitors for HR⁺/HER2^- breast cancer: an umbrella review of meta-analyses of randomized controlled trials. Front Pharmaco, 2024, 15: 1269922. doi: 10.3389/fphar.2024.1269922.
24. Shao ZM, Hao JH, Wang S, et al. Dalpiciclib (Dalp) plus endocrine therapy (ET) as adjuvant treatment for HR⁺/HER2^– early breast cancer (BC): The randomized, phase 3, DAWNA-A trial. J Clin Oncol, 2025, 43(16_SUPPL): 515. doi: 10.1200/JCO.2025.43.16_suppl.515.
25. Mamounas EP, Bandos H, Rastogi P, et al. Ten-year update: NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-42 randomized trial: extended letrozole therapy in early-stage breast cancer. J Natl Cancer Inst, 2023, 115(11): 1302-1309.
26. Davies C, Pan H, Godwin J, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet, 2013, 381(9869): 805-816.
27. Goss PE, Ingle JN, Pritchard KI, et al. Extending aromatase-inhibitor adjuvant therapy to 10 years. N Engl J Med, 2016, 375(3): 209-219.
28. Gnant M, Fitzal F, Rinnerthaler G, et al. Duration of adjuvant aromatase-inhibitor therapy in postmenopausal breast cancer. N Engl J Med, 2021, 385(5): 395-405.
29. Penault-Llorca F, Dalenc F, Chabaud S, et al. Prognostic value of EndoPredict test in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer screened for the randomized, double-blind, phase Ⅲ UNIRAD trial. ESMO Open, 2024, 9(5): 103443. doi: 10.1016/j.esmoop.2024.103443.
30. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Extending the duration of endocrine treatment for early breast cancer: patient-level meta-analysis of 12 randomised trials of aromatase inhibitors in 22 031 postmenopausal women already treated with at least 5 years of endocrine therapy. Lancet, 2025, 406(10503): 603-614.
31. Francis PA, Fleming GF, Pagani O, et al. 15-year outcomes for women with premenopausal hormone receptor-positive early breast cancer (BC) in the SOFT and TEXT trials assessing benefits from adjuvant exemestane (E) + ovarian function suppression (OFS) or tamoxifen (T) + OFS. J Clin Oncol, 2025, 43(16_suppl): 505. doi: 10.1200/JCO.2025.43.16_suppl.505.
32. Cardoso F, O’Shaughnessy J, Liu Z, et al. Pembrolizumab and chemotherapy in high-risk, early-stage, ER⁺/HER2^– breast cancer: a randomized phase 3 trial. Nat Med, 2025, 31(2): 442-448.
33. Loi S, Salgado R, Curigliano G, et al. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nat Med, 2025, 31(2): 433-441.
34. Cardoso F, Hirshfield KM, Kraynyak KA, et al. Immunotherapy for hormone receptor-positive HER2-negative breast cancer. NPJ Breast Cancer, 2024, 10(1): 104. doi: 10.1038/s41523-024-00704-9.
35. Debien V, De Caluwé A, Wang X, et al. Immunotherapy in breast cancer: an overview of current strategies and perspectives. NPJ Breast Cancer, 2023, 9(1): 7. doi: 10.1038/s41523-023-00508-3.
36. Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med, 2022, 387(1): 9-20.
37. Bardia A, Hu X, Dent R, et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med, 2024, 391(22): 2110-2122.
38. Tarantino P, Hamilton E, Tolaney SM, et al. HER2-low breast cancer: pathological and clinical landscape. J Clin Oncol, 2020, 38(17): 1951-1962.
39. Bardia A, Hurvitz S, Press M F, et al. Abstract GS2-03: GS2-03 TRIO-US B-12 TALENT: neoadjuvant trastuzumab deruxtecan with or without anastrozole for HER2-low, HR⁺ early stage breast cancer. Cancer Res, 2023, 83(5_Supplement): GS2-3. doi: 10.1158/1538-7445.SABCS22-GS2-03.
40. Esteva FJ, Katz E. Tailoring neoadjuvant therapy in human epidermal growth factor receptor 2-positive early breast cancer: recent advances and strategies. JCO Oncol Pract, 2024, 20(8): 1046-1054.
41. Liu Z, Jiao D, Zhu J, et al. SHR-A1811 as neoadjuvant therapy for HR-positive, HER2-low breast cancer: a single-arm, phase Ⅱ clinical study. J Clin Oncol, 2025, 43(16_suppl): 594. doi: 10.1200/JCO.2025.43.16_suppl.594.

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Progress in adjuvant treatment of hormone receptor-positive early breast cancer

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