Evaluating HER2DX's impact on treatment decisions for early stage HER2+ 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 observational study aims to assess how the HER2DX assay influences treatment decisions made by physicians for patients with early stage HER2+ breast cancer. It focuses on the decision-making processes within multidisciplinary tumor boards, particularly regarding the type and setting of systemic therapy. The study will evaluate the confidence of clinicians in their treatment recommendations based on the HER2DX results. Patients eligible for neoadjuvant or adjuvant therapy will be included, and informed consent will be required for participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients ≥ 18 years of age;
* Histologically confirmed HER2+ breast cancer;
* Stage I-III breast cancer without evidence of distant metastases;
* Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy);
* Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);

Exclusion Criteria:

* HER2- BC;
* Stage IV breast cancer;
* Lack of informed consent because of patient's incapable of discernment or unwilling to participate;

Where it's running

• Istituto Europeo di Oncologia
  Milan, Italy, Italy Recruiting

Study contacts

• Principal investigator: Paola Zagami — Istituto Europeo di Oncologia
• Study coordinator: Paola Zagami
• Email: paola.zagami@ieo.it
• Phone: 00390294372437

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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.