ArticleTherapeutic advances in medical oncology2024
Abemaciclib combined with endocrine therapy as adjuvant treatment for hormone-receptor-positive, HER2-, high-risk early breast cancer: 5-year Chinese population analysis of the phase III randomized monarchE study.
Article in Therapeutic advances in medical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03155997 (A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of abemaciclib plus endocrine therapy versus endocrine therapy alone in HR + and HER2-negative breast cancer; a systematic review and meta-analysis.Breast cancer research and treatment · 2025Pooled it
- A Retrospective Observational Study of Safety and Effectiveness of Abemaciclib in Chinese Patients with Breast Cancer.Advances in therapy · 2026Observational
- A prospective post-marketing observational study of abemaciclib in patients with HR+, HER2- breast cancer in China.The oncologist · 2026Observational
- Eligibility for adjuvant CDK4/6 inhibitors in HR+/HER2- early breast cancer: insights from a large cohort in central south China.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026Article
- Comparative safety signal prioritization of CDK4/6 inhibitors in breast cancer: a FAERS pharmacovigilance, machine learning, and clinical contextualization study.Frontiers in pharmacology · 2026Article
- Balancing evidence and individualization in adjuvant CDK4/6 therapy.Translational cancer research · 2025Article
- Benzimidazole-Pyrimidine Hybrids: Synthesis and Medicinal Properties.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Application status and research progress of targeted therapy drugs for hormone receptor-positive breast cancer.Frontiers in medicine · 2025Review
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Abemaciclib was the first cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved globally in the adjuvant setting for high-risk hormone-receptor positive (HR+)/human epidermal growth factor 2 negative (HER2-) early breast cancer (EBC), based on the phase III monarchE trial. Objective: To report an exploratory Chinese population analysis based on the preplanned overall survival (OS) interim analysis with 5-year efficacy results of monarchE. Design and methods: Patients with HR+/HER2-, high-risk (⩾4 positive lymph nodes, or 1-3 nodes and either tumor size ⩾5 cm, histologic grade 3, or Ki-67 ⩾20%) EBC were randomized (1:1) to abemaciclib (150 mg twice daily for 2 years) plus endocrine therapy (ET), or ET alone. This analysis included Chinese patients enrolled in mainland China, Hong Kong, and Taiwan. The primary endpoint was invasive disease-free survival (IDFS); key secondary endpoints included distant relapse-free survival (DRFS), safety, and patient-reported outcomes (PROs). Results: Overall, 501 Chinese patients were included (abemaciclib + ET, Conclusion: At this prespecified OS interim analysis, which provides 5-year data, the addition of abemaciclib to ET in Chinese patients with high-risk HR+, HER2- EBC was associated with sustained and clinically meaningful improvements in IDFS and DRFS, with acceptable safety and tolerability profiles and minimal impact on PROs. These results represent the first full report of a CDK4/6 inhibitor in Chinese patients with EBC and support the positive benefit-risk profile of adjuvant abemaciclib + ET in Chinese patients. Trial registration: ClinicalTrials.gov identifier: NCT03155997 (first posted: May 16, 2017).
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