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Report for Clinical Trial NCT04212702

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

The Landscape of ESR1 Mutations in Asian Estrogen Receptor-positive Metastatic Breast Cancer Patients Detected by Liquid Biopsy and Impact on Hormonal Therapy-based Treatments

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.

NCT04212702 Metastatic Breast Cancer
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

1 Interventions

Name: Hormonal therapy-based treatments

Description: 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
Type: Drug


Primary Outcomes

Description: The percentage of each ESR1 LBD mutation variant in Asian ER-positive/HER2-negative MBC who had received at least one line of HT

Measure: The percentage of ESR1 LBD mutation variant

Time: 12 months

Secondary Outcomes

Description: 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

Measure: Progression-free Survival (PFS)

Time: 12 months

Time Perspective: Prospective

Case-Only


There are 3 SNPs

SNPs


1 D538G

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. --- Y537C --- --- D538G ---


2 Y537C

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. --- Y537C ---

Metastatic Breast Cancer Breast Neoplasms 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. --- Y537C ---

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. --- Y537C ---


3 Y537S

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. --- Y537C --- --- D538G --- --- Y537S ---



HPO Nodes


HPO: