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Recruiting Observational

Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer

NCT06706557 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-01-11
Last updated
2026-03-24

Condition(s) studied

Advanced Metastatic Breast Cancer

Study summary

A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing. * Participants should be at advanced or metastatic setting prior to treatment. * Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion. * Patients must be accessible for follow-up.

Primary outcome measure(s)

  • circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low) — 12 months
    evaluate the mutations present in breast cancer of patients with advanced/metastatic disease e HER2-low defined with 1+ or 2+ expression levels by IHC (immunohistochemistry) technique and gene not amplified by ISH test (in situ hybridization)

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan MI Recruiting
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 NCT06706557 on ClinicalTrials.gov ↗ ← All trials in Italy