Study of Personalized HER2DX-Guided Treatment for Adults with Early-Stage HER2-Positive Breast Cancer

What this Trial Is About

Researchers are evaluating the HER2DX diagnostic assay in patients with early-stage HER2-positive breast cancer to improve how treatment decisions are made. This international phase III study compares quality of life, safety, effectiveness, and economic impact between patients receiving standard care and those receiving treatment personalized by HER2DX test results. The study focuses on patients with stage II to IIIA disease eligible for neoadjuvant therapy. Participants are randomly assigned to one of two groups Arm A receives treatment chosen by their doctor without knowledge of HER2DX test results, following standard guidelines. Arm B receives personalized treatment based on HER2DX molecular diagnosis, which classifies patients into high-risk or low-risk groups with specific chemotherapy and antibody regimens before and after surgery. Treatments include paclitaxel, trastuzumab, pertuzumab, carboplatin, docetaxel, T-DM1, or no adjuvant therapy depending on risk and response. During the study, participants undergo assessments including quality of life questionnaires EORTC QLQ-C30 and FACIT Fatigue Scale, cancer response evaluations, safety monitoring, and economic analyses for up to five years. Researchers will measure outcomes such as survival, cancer recurrence, adverse events, work productivity, and patient-reported health status. Participants will have surgery after neoadjuvant treatment and regular follow-ups to monitor their health and treatment effects throughout the study period.

Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer