Testing for specific mutations in metastatic breast cancer patients using liquid biopsy
Official title: 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
Run by European Institute of Oncology · NCT06762483 · Data updated 2026-11-12
This study is testing a new blood test to see if it can find specific gene mutations in people with certain types of metastatic breast cancer to help guide their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2030 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT06762483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women diagnosed with HR+/HER2- metastatic breast cancer who have not yet started treatment or have progressed after treatment with CDK4/6 inhibitors.
✕Probably not a fit
Patients with non-HR+/HER2- breast cancer or those who do not have a confirmed diagnosis of breast cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop and validate a testing strategy that allows for the simultaneous detection of ESR-1 and gBRCA mutations in patients with hormone receptor-positive and HER2-negative metastatic breast cancer through liquid biopsy. The approach involves creating a digital gene library to support an evidence-based diagnostic algorithm, which could enhance understanding of treatment resistance mechanisms. Participants will include those with confirmed diagnoses of the specified breast cancer types, either before starting treatment for metastatic disease or after experiencing progression following prior treatments.
Why it matters
Potential benefit: If successful, this study could lead to more effective personalized treatment strategies for patients with metastatic breast cancer.
How similar studies have gone: Other studies have shown promise in using liquid biopsy for mutation detection in various cancers, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
European Institute of oncology
Milan, Italy, Italy Recruiting
Study contacts
- Study coordinator: Nicola Fusco, MD
- Email: nicola.fusco@ieo.it
- Phone: 00390294372079
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.