Analyzing tumor DNA in patients with low HER2 advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study focuses on the analysis of circulating tumor DNA (ctDNA) in patients diagnosed with advanced or metastatic breast cancer that exhibits low levels of HER2 expression. The study aims to assess the feasibility of ctDNA analysis in this specific patient population, defined by immunohistochemistry scores of 1+ or 2+ without gene amplification. A total of 30 patients will be enrolled, and their ctDNA will be monitored to gather insights into the disease's progression and treatment response. The study is conducted at a single center, the European Institute of Oncology in Milan.

Why it matters

Who can join: the full rules

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.

Where it's running

• European Institute of Oncology
  Milan, Mi, Italy Recruiting

Study contacts

• Principal investigator: Nicola Fusco, MD — Istituto Europeo di Oncologia
• Study coordinator: Nicola Fusco, MD
• Email: nicola.fusco@ieo.it
• Phone: 00390294372079

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.