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Background: Developing guidelines for the diagnosis and treatment of common cancers in China based on the evidence-based practice, the availability of diagnosis and treatment products, and the up-to-date advances in precision medicine is one of the basic tasks of the Chinese Society of Clinical Oncology Breast Cancer (CSCO BC) Committee., Methods: Protocols with high evidence level and good availability are used as the Level I recommendations; protocols with relatively high evidence level but slightly lower expert consensus or with poor availability are used as the Level II recommendations; and protocols that are clinically applicable but with low evidence level are regarded as the Level III recommendations. Based on the findings of clinical research at home and abroad and the opinions of CSCO BC experts, the CSCO BC guidelines determine the levels of recommendations for clinical application., Results: For human epidermal growth factor receptor 2 (HER2)-positive breast cancer, a combination of trastuzumab and pertuzumab regimen were recommended as Level I recommendation for neoadjuvant and first line metastatic breast cancer. Pyrotinib is also recommended as Level I recommendation in first line and second line therapy according to the latest studies conducted in China. Antibody drug conjugates was also recommended for patients with trastuzumab progression. For triple negative breast cancer, immunotherapy in early and metastatic breast cancer was highlighted and listed as new chapters in this version of guideline. For hormone receptor (HR)-positive breast cancer, cyclin dependent kinase 4/6 (CDK4/6) was recommended in different stages, especially in adjuvant therapy. There was also a new chapter for HER2-low breast cancer stratified by HR status., Conclusions: We firmly believe that evidence-based, availability-concerned, and consensus-based guidelines will be more feasible for clinical practice in China and in other countries with similar situations., Competing Interests: Conflicts of Interest: All authors authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.org/article/view/10.21037/tbcr-24-31/coif). Z.J. serves as the Editor-in-Chief of Translational Breast Cancer Research. J.L. serves as an unpaid Managing Editor of Translational Breast Cancer Research from November 2019 to October 2024. E.S., Y.Y., J.C., Q.L., C.G., H.W., S.W., and J.W. serve as the unpaid editorial board members of Translational Breast Cancer Research from March 2024 to February 2026. C.H., K.W., Y.L., J.Z., J.N. serve as the unpaid editorial board members of Translational Breast Cancer Research from May 2023 to April 2025. X.W. serves as an unpaid editorial board member of Translational Breast Cancer Research from December 2022 to November 2024. The other author has no conflicts of interest to declare., (2024 Translational Breast Cancer Research. All rights reserved.)

Background: Significant progress has been made in immunotherapy of breast cancer (BC) with the approval of multiple immune checkpoint inhibitors (ICIs), particularly in early and metastatic triple-negative breast cancer (TNBC) settings. Most guidelines have recommended immune therapy as the important approach in BC, yet several critical aspects still require further clarification, including proper patient selection, treatment duration, optimized chemotherapy partner, predictive biomarkers, and specific considerations for Chinese patients., Methods: (I) Establishment of expert group: the expert group consists of 32 experts from departments such as medical oncology, breast surgery, and pathology; (II) literature search: mainly conducted in English databases (such as PubMed, Embase, and Cochrane Library) and Chinese databases (such as China National Knowledge Infrastructure, China Biology Medicine disc, and Wanfang Database), with a search cutoff date of April 23, 2024; (III) assessment of evidence quality and recommendation strength: evidence quality and recommendation opinions are graded based on the evidence category and recommendation level of the Chinese Society of Clinical Oncology (CSCO) guidelines; (IV) consensus formulation: on the March 2, 2024, through online consensus meeting, the consensus content is thoroughly discussed, and opinions from all experts are solicited., Results: The consensus meeting has resulted in 15 detailed recommendations, providing clearer guidance on the clinical application of immunotherapy in BC management. The core suggestions are as follows: for early-stage II-III TNBC and metastatic TNBC (mTNBC) in the first-line setting, programmed cell death protein 1 (PD-1) inhibitors can be considered. However, for hormone receptor-positive/human epidermal growth factor receptor 2-negative BC (HR + /HER2 - BC), HER2 + BC, and mTNBC in later lines of therapy, evidence is lacking to support the use of immunotherapy., Conclusions: This consensus provides a comprehensive overview of BC immunotherapy, including immunotherapy for early-stage BC and late-stage BC, immune related adverse event (irAE) management, biomarkers of immunotherapy, and future directions. The consensus consolidates these deliberations into 15 evidence-based recommendations, serving as a practical guide for clinicians to more scientifically and systematically manage the clinical application of immunotherapy., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.org/article/view/10.21037/tbcr-24-15/coif). Q.L., Y.Y., H.W. and S.W. serve as unpaid editorial board members of Translational Breast Cancer Research from March 2024 to February 2026. X.W. serves as an unpaid editorial board member of Translational Breast Cancer Research from December 2022 to November 2024. K.W., Y.L. and C.H. serve as unpaid editorial board members of Translational Breast Cancer Research from May 2023 to April 2025. Z.J. serves as the Editor-in-Chief of Translational Breast Cancer Research. The other authors have no conflicts of interest to declare., (2024 Translational Breast Cancer Research. All rights reserved.)

Background: For patients with hormone receptor-positive HER2-negeative metastatic breast cancer (HR + HER2 - MBC), switching to another cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) or targeted drugs with different mechanism are considerable treatment strategies post-CDK4/6i. However, no clinical data has been reported on which of the two strategies is more effective. In order to explore optimal treatment option post-CDK4/6i, we performed a retrospective comparative cohort study to evaluate the efficacy and safety of abemaciclib-based therapy versus tucidinostat-based therapy after progression on palbociclib., Methods: We identified patients with HR + HER2 - MBC who had received abemaciclib-based therapy or tucidinostat-based therapy after progression on palbociclib from the database of Chinese Society of Clinical Oncology Breast Cancer (CSCO BC). Baseline characteristics, efficacy and safety information of treatments were derived from seven research centers' medical records. The primary endpoint was progression-free survival (PFS), the secondary endpoints were clinical benefit rate (CBR), PFS according to PIK3CA gene type, and safety., Results: Between April 1 st 2020 and June 30 th 2022, a total of 149 patients were included, of whom 73 patients received abemaciclib plus endocrine therapy (ET), and 76 patients received tucidinostat plus ET. The majority of patients had visceral disease (124/149, 83.2%) and ≥3 metastatic organs (76/149, 51.0%), one third (48/149, 32.2%) had previously been treated ≥3 lines of ET at baseline in MBC setting. CBR was 38.4% (28/73) in abemaciclib group and 17.1% (13/76) in tucidinostat group (P=0.004). There was significant difference in PFS between abemaciclib group and tucidinostat group in both the whole population (5.0 vs. 2.0 months; hazard ratio =0.44; 95% CI: 0.31-0.64; P<0.001) and propensity score matched population. PIK3CA mutations occurred in 44.20% of patients who had undergone multigene sequencing. PIK3CA-mutant showed a negative effect on PFS of abemaciclib-based therapy. Neutropenia was the most common adverse event in both groups for any grade and grades 3-4. Common non-hematological toxicity occurred in abemaciclib group was diarrhea (27.4%), and were increased aspartate aminotransferase (AST) (26.3%), nausea (25.0%), vomiting (11.8%) and hypokalemia (13.2%) in tucidinostat group., Conclusions: Our study suggests superiority of abemaciclib-based therapy over tucidinostat-based therapy in patients progressed on palbociclib, which merits further assessment in larger and prospective trials., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.org/article/view/10.21037/tbcr-23-9/coif). YW is a full-time employee of Medical Department, Medpion (Beijing) Medical Technology Co., Ltd., Beijing and LZ is a full-time employee of Genecast (Beijing) Biotechnology Co., Ltd. Yongmei Yin, SW, and TS serve as unpaid editorial board members of Translational Breast Cancer Research from March 2022 to February 2024. JL serves as the unpaid managing editor of Translational Breast Cancer Research from November 2019 to October 2024. ZJ serves as the Editor-in-Chief of Translational Breast Cancer Research. The authors have no other conflicts of interest to declare., (2023 Translational Breast Cancer Research. All rights reserved.)

Human epidermal growth factor receptor 2 (HER2) is an important driver gene and prognostic indicator of breast cancer and also a key predictor of HER2-targeted therapies. The emerging anti-HER2 drugs have greatly changed the diagnosis and treatment modalities of breast cancer and dramatically improved the prognosis of HER2-positive breast cancer patients. To optimize the treatment of HER2 breast cancer an update of expert consensus on HER2 positive breast cancer was made to adjust the different recommendation levels from early stage to metastatic stage. Meanwhile, antibody-drug conjugate (ADC) like trastuzumab deruxtecan (T-Dxd) has been shown to have great efficacy in HER2-positive and HER2 low expression breast cancer patients. Clinically, on the basis of the original definition for HER2-negative breast cancer, patients with HER2 immunohistochemistry (IHC) 1+ or IHC 2+ and in-situ hybridization (ISH)-negative are defined as low HER2 expression (HER2-low). As both the low expression and the positive expression of the HER2 protein is clinically significant for disease treatment and prognosis, we added a new chapter of HER2 low to recommend a proper regimen for this kind of patients. In this consensus, we also talk about the importance of clinical research, real world evidence, biosimilars and so on. In addition, the whole-course management of HER2 breast cancer is even more critical during pandemic of coronavirus disease 2019 (COVID-19). An approach that gives preference to "low-toxicity regimens and oral preparations" are also recommended., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-22-48/coif). XW serves as an unpaid editorial member of Translational Breast Cancer Research from December 2020 to November 2022. SSW, CG, FJ, YY, QZ, ES and JW serve as the unpaid editorial members of Translational Breast Cancer Research from March 2022 to April 2024. SW and YL serve as the unpaid editorial members of Translational Breast Cancer Research from May 2021 to April 2023. JL serves as an unpaid Managing Editor of Translational Breast Cancer Research from November 2019 to October 2024. ZJ serves as the Editor-in-Chief of Translational Breast Cancer Research. The other authors have no conflicts of interest to declare., (2022 Translational Breast Cancer Research. All rights reserved.)

Developing guidelines for the diagnosis and treatment of common cancers in China based on the evidence-based practice, the availability of diagnosis and treatment products, and the up-to-date advances in precision medicine is one of the basic tasks of the Chinese Society of Clinical Oncology (CSCO). In recent years, the availability of medical resources has become a major concern in clinical guidelines, which is particularly important for developing countries or socioeconomically diverse countries and territories. China is the world's largest developing country, with a large territory and uneven economic and academic developments. The CSCO guidelines must take into account the differences in regional development, the availability of medicines and diagnostic methods, and the social value of cancer treatment. Therefore, for each clinical problem and intervention in the CSCO guidelines, the levels of evidence should be graded according to the currently available evidences and expert consensuses, and the grades of recommendations should be based on the availability and cost-effectiveness of the products. Protocols with high evidence level and good availability are used as the Level I recommendations; protocols with relatively high evidence level but slightly lower expert consensus or with poor availability are used as the Level II recommendations; and protocols that are clinically applicable but with low evidence level are regarded as the Level III recommendations. Based on the findings of clinical research at home and abroad and the opinions of CSCO experts, the CSCO guidelines determine the levels of recommendations for clinical application. The CSCO Guidance Working Group firmly believes that evidence-based, availability-concerned, and consensus-based guidelines will be more feasible for clinical practice. Again, any comments from our readers are greatly appreciated and will be considered in updates of these guidelines, so as to maintain the accuracy, fairness, and timeliness of the CSCO guidelines., Competing Interests: Conflicts of Interest: The authors have completed the ICMJE uniform disclosure form (available at https://tbcr.amegroups.com/article/view/10.21037/tbcr-22-21/coif). ZJ serves as the Editor-in-Chief of Translational Breast Cancer Research. JL serves as an unpaid Managing Editor of Translational Breast Cancer Research. ES, XW, YY, JC, SW and YL serve as unpaid editorial board members of Translational Breast Cancer Research from March 2022 to February 2024. CH, KW, JN serve as unpaid editorial board members of Translational Breast Cancer Research from May 2021 to April 2023. The authors have no other conflicts of interest to declare., (2022 Translational Breast Cancer Research. All rights reserved.)