Study to See How the HER2DX Test Affects Treatment Choices for Adults With Early Stage HER2 Breast Cancer Stages 1-3

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 ATax and TP 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 ATax and TP 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.

Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX