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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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