Clinical Trials in Italy / NCT06762483
Recruiting
Observational
Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients,
NCT06762483 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Breast Cancer, Metastatic
Study 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
Eligibility
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 primary tumor should be treated according to the standard of care.
* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Exclusion Criteria:
* Unable to provide written informed consent
Primary outcome measure(s)
- the creation of a digital gene library to support an evidence-based diagnostic algorithm — 2 years
Optimize the patient journey for individuals with metastatic breast cancer (mBC) by enhancing the care pathway and promoting access to testing for ESR1 and gBRCA mutations.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| European Institute of oncology | Milan | Italy | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06762483 on ClinicalTrials.gov ↗ ← All trials in Italy