Actively Recruiting
Prospective Observational Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Early Stage HER2-Positive Breast Cancer
Led by European Institute of Oncology · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how the HER2DX test influences treatment decisions for patients with early stage (stage I-III) HER2-positive breast cancer. The study focuses on understanding how this test affects the choices made by doctors and multidisciplinary tumor boards regarding systemic therapy, as well as how confident clinicians feel about their treatment recommendations. Participants receive standard neoadjuvant or adjuvant drug treatments for HER2-positive breast cancer. In the neoadjuvant setting, patients are treated with a combination of A→Tax and T/P drugs. In the adjuvant setting, treatment varies depending on lymph node involvement: patients without lymph node involvement receive Tax and T with or without endocrine therapy, while those with lymph node involvement receive A→Tax and T/P with or without endocrine therapy. During the study, doctors will observe how treatment decisions are influenced by the HER2DX test results from the start of treatment through one year. Researchers will assess the impact on decision-making and the confidence of the clinical team. Participants will undergo standard care and treatment monitoring as part of their cancer therapy, with no additional interventions specified. The total observation period for measuring the primary outcome is 12 months.
CONDITIONS
Brief Title
Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Histologically confirmed HER2-positive breast cancer
- Stage I to III breast cancer without distant metastases
- Candidates for neoadjuvant or adjuvant therapy with locoregional treatment such as surgery or radiotherapy
- Written informed consent signed by the patient for study procedures
You will not qualify if you...
- HER2-negative breast cancer
- Stage IV breast cancer
- Lack of informed consent due to incapacity or unwillingness to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive standard neoadjuvant or adjuvant drug treatments for HER2-positive breast cancer as part of their clinical care.
Visits as required by routine clinical treatment
Duration - Up to the end of treatment at 12 months
Participants are followed to assess treatment impact and outcomes after completing therapy.
Visits as required by routine clinical care
Trial Site Locations
Total: 1 location
1
Istituto Europeo di Oncologia
Milan, Italy, Italy
Actively Recruiting
Research Team
P
Paola Zagami
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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