The investigator propose a prospective study using blood samples (liquid biopsy) of estrogen receptor (ER)-positive metastatic breast cancer (MBC) patients to understand the prevalence of estrogen receptor 1 (ESR1) mutation variants and the correlation with hormonal therapy (HT)-based treatment resistance in Asian ER-positive/human epidermal growth receptor-2 (HER2)-negative MBC population.
The investigator will use next-generation targeted sequencing covering the entire ESR1 ligand-binding domain (LBD) region to understand 1. the spectrum and prevalence of specific ESR1 mutation variants in Asian women, and 2. the preliminary correlation of Asian-specific prevalent ESR1 LBD mutation variants such as Y537C with treatment efficacy. For the second purpose, the investigator will specifically focus on patients with ESR1 Y537C mutation, while the results from patients with wild type ESR1 and patients with D538G or Y537S mutant will be severed as control for preliminary comparison.
Study Type
OBSERVATIONAL
Enrollment
123
Hormonal therapy-based treatments, ex. HT single agent, HT plus other targeted therapy, HT plus everolimus, HT plus metronomic oral chemotherapy or oral chemotherapy only
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
The percentage of ESR1 LBD mutation variant
The percentage of each ESR1 LBD mutation variant in Asian ER-positive/HER2-negative MBC who had received at least one line of HT
Time frame: 12 months
Progression-free Survival (PFS)
PFS of patients who are treated with everolimus plus HT with either ESR1 wild type or different Asian-specific prevalent ESR1 LBD mutation variants such as Y537C
Time frame: 12 months
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