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Background: Gemcitabine plus capecitabine (GX) shows survival benefit and manageable safety in patients with advanced triple-negative breast cancer (TNBC) but there is a paucity of phase III trial evidence. We aimed to compare the efficacy and safety of GX with gemcitabine plus carboplatin (GC) as first-line treatment for patients with advanced TNBC and validate the prognostic value of tumor-infiltrating lymphocytes (TILs). Methods: Patients with advanced TNBC were randomly assigned 1:1 to receive gemcitabine (1000 mg/m2) on days 1 and 8 plus oral capecitabine (1000 mg/m2 twice a day) on days 1–14, or gemcitabine (1000 mg/m2) on days 1 and 8 plus carboplatin area under curve 2 on days 1 and 8. The primary endpoint was progression-free survival (PFS). TILs were analyzed by immunohistochemistry. The margin used to establish non-inferiority was 1.2. Results: In all, 187 patients were randomly assigned, with 93 in GX and 94 in GC. Median PFS was 6.1 months in the GX arm compared with 6.3 months in the GC arm. The hazard ratio for PFS was 1.148, and a 95% CI was 0.856–1.539, exceeding the non-inferiority margin of 1.2. The median overall survival (OS) was 21.0 months in the GX arm compared with 21.5 months in the GC arm. The safety profile for the GX regimen was superior to the GC regimen, especially regarding hematological toxicity. Patients with high CD8+ TILs had significantly longer PFS and OS compared with patients with low CD8+ TILs. In the high CD8+ TIL group, the GC arm had prolonged PFS and OS compared with the GX arm. Conclusion: The trial did not meet the prespecified criteria for the primary endpoint of PFS in patients with advanced TNBC. Moreover, the GC regimen showed better efficacy compared with the GX regimen in patients with high CD8+ TILs. However, the GX regimen should be considered in patients who cannot tolerate hematological toxicity. Trial registration: ClinicalTrials.gov identifier: NCT02207335. [ABSTRACT FROM AUTHOR]

Objective: Our study evaluated the renal safety of abemaciclib plus endocrine therapy (ET) with bisphosphonate as a treatment option for hormone receptor positive, human epidermal growth factor receptor 2 (HER‐2) negative (HR+/HER2−) advanced breast cancer (ABC), especially with bone metastasis. Methods: Data were collected from HR+/HER2− ABC patients who received abemaciclib with ET between March 2021 and May 2022 in a single medical center in China. We performed an analysis of the change in serum creatine (Cr) and creatine clearance (CrCl), time to first abnormal Cr value, and Common Terminology Criteria for Adverse Events grade of increased creatinine. Results: A total of 210 patients were included in the final analysis, with a median age of 56 years and a median weight of 65 kg. Any grade laboratory‐assessing increased Cr occurred in 87.1% of patients, while CrCl rarely went down to 30 ml/min. Associations between start dose with grade of increased Cr and menopausal status with alert value, which is defined as creatinine clearance <30 ml/min, were indicated. Conclusion: This study shows that abemaciclib combined with bisphosphonate would be safe for renal function in HR+/HER2− ABC patients with bone metastases. [ABSTRACT FROM AUTHOR]

Purpose: Approximately 50-74% of patients with metastatic HER2-positive breast cancer do not respond to trastuzumab, with 75% of treated patients experiencing disease progression within a year. The combination of pyrotinib and capecitabine has showed efficacy in these patients. This study evaluates the efficacy and safety of pyrotinib combined with metronomic vinorelbine for trastuzumab-pretreated HER2-positive advanced breast cancer patients., Materials and Methods: In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety., Results: From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cut-off date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% CI: 8.3-18.5). With all patients evaluated, an ORR of 38.9% (95% CI: 23.1-56.5%) and a DCR of 83.3% (95% CI: 67.2-93.6%) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs., Conclusion: Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.

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: The purpose of this study was to investigate the therapeutic efficacy and prognosis of serum HER2 (sHER2) in patients with advanced breast cancer., Methods: We analyzed the sHER2 levels of 200 patients with advanced breast cancer receiving first or second line treatment, the tissue HER2 (tHER2) level was also analyzed. Indicators of therapeutic efficacy and prognosis were objective response rate (ORR), disease control rate (DCR), and time to progression (TTP)., Results: The baseline sHER2 level was high in 132 patients and low in 68 patients. The high level of sHER2 is correlated with molecular subtype ( p =0.016), visceral metastasis ( p <0.001), liver metastasis ( p <0.001), tissue HER-2 (tHER2) ( p =0.001), and, among tHER2-low tumors (59 patients), the baseline sHER2 high level was associated with a higher proportion of brain metastasis. The ORR of patients with baseline sHER2 high level is higher than those with baseline sHER2 low level ( p =0.026). The TTP of patients with baseline sHER2 low level is longer than the patients with baseline sHER2 high level ( p =0.024). For patients with baseline sHER2 high level, a significant decrease in sHER2 after two cycles of treatment indicates higher ORR, DCR, and an extension of TTP. After multiple cycles of treatment, for patients with tHER-2 positive and baseline sHER2 high level, the DCR in the sHER2 decrease in the negative group was higher than that in the continuous positive group ( p =0.037). Patients with a rapid decline type of sHER2 dynamic change curve had higher ORR and prolonged TTP compared with patients with other types of sHER2 dynamic change curve. There is no correlation between OS and sHER2 levels., Conclusion: Our study showed that patients with advanced breast cancer had a high level of sHER2 at recurrence, regardless of whether they are tHER2 positive or negative. Dynamic detection of sHER2 can help predict therapeutic efficacy and prognosis, regardless of whether tHER-2 is positive or negative., Competing Interests: The authors declare that they have no conflicts of interest in this work., (© 2024 Wang et al.)

Breast cancer is one of the most common malignancies among women worldwide. According to the International Agency for Research on Cancer, breast cancer affected more Chinese women than any other cancer in 2020. The brain is an increasingly common metastatic sites of breast cancer. Although the risk of developing brain metastases (BMs) is lower in breast cancer than in lung cancer and melanoma, due to its high prevalence, it is the second most common cause of BM among solid tumors, being second only to lung cancer. The incidence of breast cancer brain metastasis (BCBM) differs by molecular subtype. Half of patients with advanced human epidermal growth factor receptor-2 (HER2)-positive and one-third of patients with triple-negative breast cancer (TNBC) develop BM. The clinical manifestations of leptomeningeal metastasis (LM) are often non-specific and may manifest as a variety of signs and symptoms, mainly including brain parenchyma involvement and meningeal irritation syndromes cranial nerve involvement, increased intracranial pressure, and progressive brain dysfunction. Therefore, the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Committee has developed this expert consensus on BM, in an effort to improve the overall prognosis of BCBM and promote the standardized diagnosis and treatment of this disease. During the development of this expert consensus, we carried out a comprehensive literature review and referred to some of the most authoritative guidelines in China and abroad. In this consensus, we will discuss clinical manifestations, imaging examinations, pathological diagnosis, treatments, prognosis, follow-up and monitoring. We hope this consensus will be of help to all the clinicians majored in breast cancer and other similar professions., 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-22-30/coif). ZJ serves as the Editor-in-Chief of Translational Breast Cancer Research from November 2019 to October 2024. JC, YL, CH serve as unpaid Editorial Board Members of Translational Breast Cancer Research from May 2021 to April 2023. 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.)