ArticleESMO open2026
Integrating baseline ctDNA-derived tumor metrics enhances risk stratification in HR-positive/HER2-negative advanced breast cancer: a real-world multicenter cohort study from Austria.
Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAdvances in endocrine therapies for hormone receptor (HR)-positive/HER2-negative advanced breast cancer (ABC) continue to transform care and significantly improve patient outcomes. However, the integration of molecular and clinical risk stratification into guiding individualized treatment selection remains a key challenge. We therefore evaluated whether the integration of baseline circulating tumor DNA (ctDNA)-derived tumor metrics enhances risk stratification among patients receiving early lines of treatment of HR-positive ABC in a real-world multicenter cohort of patients in Austria.
methodsPatients with HR-positive/HER2-negative ABC treated at multiple Austrian centers were included. CtDNA was analyzed using a 77-gene panel (AVENIO ctDNA Expanded Kit). Tumor fraction (TFx) was estimated via two complementary approaches: untargeted aneuploidy assessment using mFAST-SeqS, and the highest variant allele frequency (hVAF) from the AVENIO assay. Somatic variants and single, binary, and three-level composite TFx metrics were assessed for their association with progression-free and overall survival (PFS, OS).
resultsWe analyzed 225 ctDNA samples from 184 patients [128 before first-line (1L) and 76 before second-line (2L) treatment], including 40 paired samples. Overall TFx was low (median z-score 2.49; range -0.5-208.3), with higher levels in 2L, although the difference did not reach statistical significance (P = 0.058). In contrast, the hVAF was significantly higher in the 2L cohort (P = 0.007). Somatic variant burden was significantly increased in 2L (P < 0.001), with notably more frequent ESR1 mutations (26.7% versus 7.1% in 1L). Median PFS was 29.2 months in 1L and 6.0 months in 2L, while median OS was 57.3 months and 16.1 months, respectively. TP53 and ESR1 mutations, and all ctDNA-based metrics were significantly associated with PFS and OS, with a three-level composite ctDNA variable showing the highest prognostic discrimination.
conclusionsOur findings demonstrate that integrating baseline ctDNA-derived TFx metrics with established clinical variables significantly improves risk stratification in HR-positive/HER2-negative ABC.
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