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

European Institute of Oncology30 enrolled

Overview

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

Prospective single-center feasibility study of 30 patients with carcinoma breast with low levels of HER2 expression, defined as 1+ or 2+ expression levels by the IHC technique (immunohistochemistry) and the gene not amplified by the ISH test (in situ hybridization)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Advanced Metastatic Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

European Institute of Oncology

Milan, MI, Italy

RECRUITING

Outcomes

Primary Outcomes

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

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)

Time frame: 12 months

Central Contacts

Nicola Fusco, MD

CONTACT

00390294372079 nicola.fusco@ieo.it

francesca lombardi, biologist

CONTACT

00390257489425 francesca.lombardi@ieo.it

Data from ClinicalTrials.gov

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