ArticleTherapeutic advances in medical oncology2025
Real-world analysis of HER2-ultralow in HR+/HER2- metastatic breast cancer: prevalence and first-line chemotherapy outcomes.
Article in Therapeutic advances in medical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Interplay between HER2-Low status, hormone receptor expression, and therapeutic response to cyclin-dependent kinase 4/6 inhibitors as first-line treatment in luminal-like metastatic breast cancer: The CYCLHER study.Breast (Edinburgh, Scotland) · 2026Observational
- Redefining HER2 in Breast Cancer: From Conventional Positivity to Low and Ultralow in the New Era of Antibody-Drug Conjugates.Cancer research and treatment · 2026Review
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11 authors.
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Abstract
Background: HER2-ultralow is an emerging subgroup of metastatic breast cancer (mBC). However, despite an increasing interest, limited data exist on its prevalence and outcomes, especially among patients receiving standard first-line chemotherapy. Objectives: This study assessed the prevalence and outcomes of HER2-ultralow mBC in a real-world cohort of hormone receptor-positive (HR+)/HER2-negative patients receiving first-line standard-of-care (SOC) chemotherapy. Design: A retrospective, single-center cohort study. Methods: We included HR+/HER2-negative mBC patients treated with SOC between January 2016 and February 2023. Patient data were reviewed from electronic health records. HER2-zero tumors (immunohistochemistry 0) were rescored by expert pathologists using the American Society of Clinical Oncology/College of American Pathologists guidelines to distinguish HER2-ultralow from HER2-null cases. Real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) were estimated using Kaplan-Meier and multivariable Cox regression models. Results: Among 320 patients (median age, 62.4 years), 72.8% had visceral metastases, and 17.5% had bone-only disease. Previous CDK4/6 inhibitor treatment was reported in 43.4%. Rescoring identified 15.6% with HER2-ultralow, 61.9% with HER2-low, and 22.5% with HER2-null tumors. The median follow-up was 39.4 months (95% confidence interval (CI), 37.1-47.6). Median rwPFS was 7.9 months (95% CI, 4.6-19.0), 7.3 months (95% CI, 6.4-9.1), and 6.2 months (95% CI, 4.6-8.9) for HER2-ultralow, HER2-low, and HER2-null groups, respectively. Median rwOS was 19.5 months (95% CI, 10.7-33.4), 21.5 months (95% CI, 19.0-25.8), and 16.6 months (95% CI, 11.9-23.6). In patients previously treated with CDK4/6 inhibitors, median rwPFS was 4.6 months (95% CI, 2.7-21.4), 6.1 months (95% CI, 5.5-7.3), and 5.6 months (95% CI, 3.8-8.7). Conclusion: HER2-ultralow accounts for 15.6% of HR+/HER2-negative mBC cases and demonstrates outcomes comparable to HER2-low with SOC chemotherapy.
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