ESR1 Mutations in Metastatic Hormone Receptor‑Positive Breast Cancer in Greece
Official title: Recording ESR1 Mutations in Metastatic Hormone Receptor-Positive Breast Cancer in the Greek Population: A Non-Interventional, Retrospective and Prospective Observational Study of Clinical Practice Data and Treatment Utilization Patterns in Routine Care
Run by Hellenic Cooperative Oncology Group · NCT07899463 · Data updated 2026-11-12
This study tests how common ESR1 mutations are in Greek patients with advanced hormone receptor–positive, HER2‑negative breast cancer and looks at how those mutations relate to disease features and real-world treatment patterns.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Hellenic Cooperative Oncology Group Academic / other |
| Locations | 1 site (Athens) |
| Status | Recruiting |
| Started | May 13, 2025 |
| Main results expected | May 15, 2027 |
| Study ends | October 15, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07899463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+ years) residing in Greece with histologically confirmed metastatic HR-positive, HER2-negative breast cancer who have undergone ESR1 mutation testing.
✕Probably not a fit
Patients whose tumors do not harbor ESR1 mutations or who do not have data available from routine care may not see direct benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective and prospective observational study conducted in routine clinical practice in Greece, aiming to describe the prevalence of ESR1 mutations among patients with metastatic HR-positive/HER2-negative breast cancer who have already undergone ESR1 testing. Data are drawn from medical records and standard care visits without any additional procedures or visits. The primary endpoint is the epidemiology of ESR1 mutations in the Greek patient population, while secondary endpoints examine associations with prior therapies and other biomarkers. Personal identifiers are pseudonymized to protect privacy. Optional translational research may collect biological material from consenting participants.
Why it matters
Potential benefit: If successful, the study could improve understanding of how ESR1 mutations relate to treatment history and outcomes, potentially guiding future personalized care for Greek patients.
How similar studies have gone: Previous observational work in other populations has shown ESR1 mutation prevalence and its associations, supporting the feasibility of this approach in Greece.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients, regardless of race, residing in Greece, aged 18 years or older at the start of treatment. Patients with histologically confirmed metastatic breast cancer with positive hormone receptors and negative HER2 status. Patients undergoing ESR1 mutation testing. Exclusion Criteria: * Patients with metastatic hormone receptor-positive breast cancer who have not undergone ESR1 mutation testing.
Where it's running
-
Hellenic Cooperative Oncology Group
Athens, Greece Recruiting
Study contacts
- Study coordinator: Eleni Galani
- Email: eleni_galani@yahoo.gr
- Phone: +30 6944172478
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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.