BACKGROUND: In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2- advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis. METHODS: In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2- ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg on days 1 and 15 of cycle 1 and then on day 1 of each subsequent cycle) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL). RESULTS: In cohort A (abemaciclib: n  = 207; placebo: n  = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs . placebo (28.27 months vs . 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348-0.649). In cohort B (abemaciclib: n  = 104; placebo: n  = 53), abemaciclib plus fulvestrant improved median PFS vs . placebo (11.41 months vs . 5.59 months, HR: 0.480; 95% CI: 0.322-0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553-1.443; cohort B: HR: 0.512, 95% CI: 0.281-0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs . placebo. CONCLUSIONS: Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life. TRIAL REGISTRATION ClinicalTrials.gov (NCT02763566).
Humans ; Female ; Fulvestrant/therapeutic use* ; Breast Neoplasms/metabolism* ; Aminopyridines/therapeutic use* ; Benzimidazoles/therapeutic use* ; Middle Aged ; Aromatase Inhibitors/therapeutic use* ; Aged ; Receptor, ErbB-2/metabolism* ; Adult ; Letrozole/therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Anastrozole/therapeutic use*

With the advent of the precision cancer therapy era, neoadjuvant therapy has become the standard therapy for certain types of breast cancer. Neoadjuvant therapy is a fundamental treatment plan implemented at the time of disease diagnosis, and its efficacy can guide the formulation of subsequent adjuvant therapy strategies. Building on the efficacy of neoadjuvant therapy and medication regimens, in conjunction with evidence-based medicine and healthcare policy, developing adjuvant therapy strategies for breast cancer following neoadjuvant therapy has the benefit of providing more precise treatment options for patients.

With the advent of the precision cancer therapy era, neoadjuvant therapy has become the standard therapy for certain types of breast cancer. Neoadjuvant therapy is a fundamental treatment plan implemented at the time of disease diagnosis, and its efficacy can guide the formulation of subsequent adjuvant therapy strategies. Building on the efficacy of neoadjuvant therapy and medication regimens, in conjunction with evidence-based medicine and healthcare policy, developing adjuvant therapy strategies for breast cancer following neoadjuvant therapy has the benefit of providing more precise treatment options for patients.

The comprehensive diagnosis and treatment of advanced breast cancer has entered the era of"accurate classification and precise stratification",and is moving towards the road of personalized precision medicine.In 2023,significant breakthroughs have been achieved in the research on different molecular classifications of advanced breast cancer,influencing clinical guidelines and transforming clinical practice.The primary focus of research for hormone receptor positive advanced breast cancer lies in selecting appropriate treatments for patients who have failed cyclin-dependent kinase 4 and 6(CDK4/6)inhibitors.Advanced breast cancer with low human epidermal growth factor receptor 2(HER2)expression has emerged as a promising treatment direction,with T-DXd being an important therapeutic option.With the release of results from the PHILA study,a new era has begun for first-line treatment of HER2-positive advanced breast cancer.Simultaneously,T-DXd has become the preferred choice in clinical practice following tyrosine kinase inhibitor failure.Research related to immune and targeted therapy for advanced triple-negative breast cancer(TNBC)is also progressing rapidly,yielding positive outcomes in studies such as TORCHILIGHT and BEGONIA.Additionally,ongoing clinical studies on precision treatment based on the"Fudan classification"for TNBC are expected to revolutionize current treatment approaches.This paper summarized major advancements in clinical research on advanced breast cancer in 2023 according to various molecular classifications,aiming to provide improved reference and guidance for clinical management.

BACKGROUND: Endocrine therapy (ET) and ET-based regimens are the preferred first-line treatment options for hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (HR+/HER2- MBC), while chemotherapy (CT) is commonly used in clinical practice. The aim of this study was to investigate the efficacy and clinical outcome of ET and CT as first-line treatment in Chinese patients with HR+/HER2- MBC. METHODS: Patients diagnosed with HR+/HER2-MBC between January 1st, 1996 and September 30th, 2018 were screened from the Chinese Society of Clinical Oncology Breast Cancer database. The initial and maintenance first-line treatment, progression-free survival (PFS), and overall survival (OS) were analyzed. RESULTS: Among the 1877 included patients, 1215 (64.7%) received CT and 662 (35.3%) received ET as initial first-line treatment. There were no statistically significant differences in PFS and OS between patients receiving ET and CT as initial first-line treatment in the total population (PFS: 12.0 vs. 11.0 months, P = 0.22; OS: 54.0 vs . 49.0 months, P =0.09) and propensity score matched population. For patients without disease progression after at least 3 months of initial therapy, maintenance ET following initial CT (CT-ET cohort, n = 449) and continuous schedule of ET (ET cohort, n = 527) had longer PFS than continuous schedule of CT (CT cohort, n = 406) in the total population (CT-ET cohort vs. CT cohort: 17.0 vs . 8.5 months; P <0.01; ET cohort vs . CT cohort: 14.0 vs . 8.5 months; P <0.01) and propensity score matched population. OS in the three cohorts yielded the same results as PFS. CONCLUSIONS ET was associated with similar clinical outcome to CT as initial first-line treatment. For patients without disease progression after initial CT, switching to maintenance ET showed superiority in clinical outcome over continuous schedule of CT.
Humans ; Female ; Breast Neoplasms/metabolism* ; Receptor, ErbB-2/metabolism* ; Progression-Free Survival ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Disease Progression ; Treatment Outcome

Triple negative breast cancer (TNBC) is a special type of breast cancer. At present, the major treatment for TNBC is chemotherapy. Neoadjuvant therapy and obtained pathology completed response could bring the TNBC patients better prognosis. The most used TNBC chemotherapy protocols are established on the basis of anthracycline and taxane. Through the thorough knowledge of molecular mechanism of TNBC, neoadjuvant therapy protocols have optimized, including the use of platinum, immune checkpoint inhibitors and poly-ADP-ribose polymerase inhibitors, and assumed positive outcome for TNBC patients.

Triple negative breast cancer (TNBC) is a special type of breast cancer. At present, the major treatment for TNBC is chemotherapy. Neoadjuvant therapy and obtained pathology completed response could bring the TNBC patients better prognosis. The most used TNBC chemotherapy protocols are established on the basis of anthracycline and taxane. Through the thorough knowledge of molecular mechanism of TNBC, neoadjuvant therapy protocols have optimized, including the use of platinum, immune checkpoint inhibitors and poly-ADP-ribose polymerase inhibitors, and assumed positive outcome for TNBC patients.

In the past two decades, with the introduction of NCCN guidelines, the establishment of a standardized diagnosis and treatment system for breast cancer had begun. The Chinese version of the NCCN guidelines, which combines international standards and Chinese characteristics, was then developed to guide clinical practice. Since 2011, Chinese experts have entered St. Gallen International Expert Consensus Group, and to introduce the latest therapy concepts. On this basis, the Chinese Society of Clinical Oncology has developed guidelines for diagnosis and treatment in line with product accessibility and expert opinions to help clinicians choose the best treatment option. The latest Chinese Society of Clinical Oncology Breast Cancer Guideline will further contribute to the establishment of a standardized diagnosis and treatment system for breast cancer.

Real-world study is increasingly becoming an important source of evidence for changing clinical practice, especially for clinical problems that can′t be randomized. In recent years, real-world research in the field of breast cancer has gradually became a boom. Existing research results have begun to assist in the epidemiological analysis of breast cancer, promote the approval of rare diseases diagnosis and indication, and promote the analysis of real-world treatment status and evaluation of curative effects. Chinese scholars have also established databases and carried out relevant real-world research, providing real-world evidence for clinical practice in China. But domestic research is still in its infancy. The number of real-world research literature published by domestic scholars is relatively small, and there is a lack of pragmatic randomized clinical trial and real-world research for decision-making. In the future, we need to take advantage of the abundant diagnosis and treatment resources, further improve the database, and carry out real-world study on drug development based on population data in China.

Human epidermal growth factor receptor-2 (HER-2) tyrosine kinase inhibitors (TKI) is the targeted drug of HER-2-positive breast cancer. Lapatinib, pyrotinib and neratinib, as ErbB family TKIs, have been approved by National Medical Products Administration and applied in the treatment of HER-2 positive breast cancer in China. The most common adverse effects (AEs) of TKI agents include diarrhea, drug-induced liver injury (DILI), nausea, vomiting, skin toxicity, cardiotoxicity and oral mucositis. The Breast Cancer Expert Group of Chinese Society of Clinical Oncology (CSCO) summarized the incidence and characteristics of AEs of TKI, evaluated the manifestations and severity of AEs, and formulated the consensus of the management of common AEs based on the clinical experiences and updated advances from domestic and abroad studies. This consensus aims to provide the practical strategy for clinicians in the management of ErbB-family TKI-related AEs in China, and eventually enhance the patients′ compliance and improve the therapeutic efficacy.