Observational studyThe oncologist2026
A prospective post-marketing observational study of abemaciclib in patients with HR+, HER2- breast cancer in China.
Observational study in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
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Who cites it
1 citing paper in PubMed.
- A Retrospective Observational Study of Safety and Effectiveness of Abemaciclib in Chinese Patients with Breast Cancer.Advances in therapy · 2026Observational
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundAbemaciclib is approved for hormone-receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) locally advanced/metastatic breast cancer (ABC) and high-risk early BC (EBC) in China. This prospective observational study describes real-world abemaciclib safety and effectiveness among Chinese patients with HR+/HER2- EBC/ABC.
methodsAdults with HR+/HER2- EBC/ABC who received abemaciclib between Mar-2022 and Jan-2024 across 32 Chinese centers were enrolled. Primary objective was to evaluate treatment-emergent adverse event (TEAE) and serious AE (SAE) incidence within 24 weeks of treatment. Secondary objective was to describe Week 24 event-free survival (EFS).
resultsAmong 387 patients with EBC and 539 with ABC (median age: 50.0 and 55.0 years, respectively), 89.1% and 82.4% received 150 mg twice daily initially. Abemaciclib was combined with aromatase inhibitors in 95.6% (EBC) and 60.5% (ABC) patients, and fulvestrant in 38.0% (ABC). TEAEs occurred in 85.5% (EBC) and 81.8% (ABC) patients (commonly diarrhea, neutrophil count decreased, and white blood cell count decreased), and SAEs in 3.9% and 7.4%. AEs led to discontinuation in 4.4% (EBC) and 7.2% (ABC) patients. Diarrhea was the most common AE leading to discontinuation (2.1% [EBC] and 1.7% [ABC]). Most patients who discontinued treatment due to AEs had no dose modification, while most with dose reduction/interruption remained on abemaciclib. Week 24 EFS rates (95% CI) were 99.7% (97.6-100.0; EBC) and 85.1% (81.3-88.2; ABC).
conclusionsReal-world safety, tolerability, and effectiveness of abemaciclib in Chinese patients with HR+/HER2- EBC and ABC were consistent with clinical trials, with no new safety signals, supporting its positive real-world benefit-risk profile.
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