Abstract
512Background: PALOMA-3 is a randomized, double-blind, phase III study comparing P+F with fulvestrant plus placebo (F+Pla) in pre- and postmenopausal women with HR+/HER2– MBC that progressed on prior endocrine therapy. Recent studies have implicated ESR1 mu as a mechanism for acquired endocrine resistance in MBC. ctDNA assessed in plasma is a potential surrogate for a tumor’s genetic profile. Here, we assess the relationship between ctDNA ESR1 mu status and palbociclib sensitivity, and the reproducibility of ESR1 ctDNA analysis. Methods: 396 baseline plasma samples from 521 pts enrolled in PALOMA-3 were collected and consented for use in this study. DNA was extracted from 2 mL aliquots using the QIAamp Circulating Nucleic Acid Kit and 12 ESR1 ligand-binding domain mus were analyzed in exons 5, 7, and 8 by Sysmex Inostics. To assess reproducibility of ESR1 mu analysis, separate samples were analysed by droplet digital PCR. Results: ESR1 mus were detected in 106 (26.8%) of the 395 plasma samples tested, mos...
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