Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Li
Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+/HER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm
| Condition(s) | Breast Cancer, Metastatic |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+/HER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm |
| Who can participate | Inclusion Criteria: * Participants must have a confirmed diagnosis of estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PgR+) breast cancer through histological and/or cytological examination by the local laboratory Participants must exhibit HER2-negative breast cancer 1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing. * Participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (CDK)4/6 inhibitors. However, the prima |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | European Institute of Oncology |
| Locations | Milan, Italy, Italy |
| Start date | 2024-12-20 |
| NCT ID | NCT06762483 |
| Official listing | https://clinicaltrials.gov/study/NCT06762483 |