[Consensus on recurrence risk and clinical management of HR+/HER-2- early breast cancer (2025 edition)].

Abstract

Breast cancer is the most common malignancy among women worldwide, with relatively high morbidity and mortality rates among Chinese women, posing a serious threat to female health. HR+/HER-2- breast cancer is the most common subtype, accounting for approximately 70% of all breast cancers. The vast majority of patients are diagnosed with early breast cancer (EBC) at initial presentation. Stage Ⅱ-Ⅲ EBC constitutes a substantial proportion of cases among Chinese patients, with a significantly younger age of onset observed nationally. Even after standard endocrine therapy, patients still face short-term and long-term recurrence risks, and the risk of recurrence persists lifelong. In recent years, large-scale real-world studies from the National Cancer Center and other institutions, both domestically and internationally, have shown that for stage Ⅱ-Ⅲ HR+/HER-2- EBC patients, those with lymph node positivity and lymph node negative patients with high-risk factors have a significantly higher risk of recurrence and death. The postoperative 5-year recurrence rate for lymph node negative patients with high-risk factors can reach 15%, similar to the recurrence rate of N1 patients. These findings have updated the clinical understanding of defining high-risk patients and raised new requirements for EBC recurrence risk assessment and definition. On the other hand, the clinical management of recurrence risk in early HR+/HER-2- breast cancer has consistently received significant attention. From the initial adjuvant chemotherapy to the entire process of adjuvant endocrine therapy, in recent years, with the publication of clinical trial results for novel targeted agents such as CDK4/6 inhibitors (CDK4/6i) and PARP inhibitors (PARPi) and the subsequent approval of their indications, the treatment paradigm for HR+/HER-2- EBC has gradually evolved from traditional endocrine therapy to a selective strategy of intensified treatment combining endocrine therapy with targeted agents. This underscores the critical importance of precise recurrence risk assessment and optimization of treatment decisions. To assist clinicians in scientifically and accurately assessing recurrence risk and tailoring individualized intensified adjuvant treatment regimens for patients, the Breast Cancer Expert Committee of the National Cancer Quality Control Center, the Professional Committee of Drug Clinical Research of Chinese Anti-Cancer Association, and the Professional Committee of Breast Cancer of the Chinese Anti-Cancer Association, incorporating advances in clinical research on early breast cancer both domestically and internationally and expert opinions, have formulated the "Consensus on Recurrence Risk and Clinical Management of HR+/HER-2- Early Breast Cancer(2025 edition)". It aims to provide a standardized reference for recurrence risk stratification and clinical management of HR+/HER-2-EBC patients, further enhancing patient treatment benefits and quality of life, and maximizing the potential for cure.