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Mutations in  ESR1  have been associated with resistance to aromatase inhibitor (AI) therapy in patients with ER+ metastatic breast cancer. Little is known of the impact of these mutations in patients receiving selective oestrogen receptor degrader (SERD) therapy. In this study, hotspot mutations in  ESR1  and  PIK3CA  from ctDNA were assayed in clinical trial samples from ER+ metastatic breast cancer patients randomized either to the SERD fulvestrant or fulvestrant plus a pan-PI3K inhibitor.  ESR1  mutations are present in 37% of baseline samples and are enriched in patients with luminal A and  PIK3CA -mutated tumours.  ESR1  mutations are often polyclonal and longitudinal analysis shows distinct clones exhibiting divergent behaviour over time.  ESR1  mutation allele frequency does not show a consistent pattern of increases during fulvestrant treatment, and progression-free survival is not different in patients with  ESR1  mutations compared with wild-type patients.  ESR1  mutations are not associated with clinical resistance to fulvestrant in this study.

Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant