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Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer — DEFINITIVE  

HER2-positive Breast Cancer Clinical Trial

Official title:
Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer

Clinical Trial Summary

The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer. Patients randomized to arm A will receive adjuvant treatment by physician´s choice, blinded to the diagnostic HER2DX test results. Patients randomized to Arm B will receive personalized treatment according to HER2DX results.

Clinical Trial Description

This is an international, multicenter, prospective, randomized, two-arm, open-label, phase III study to evaluate the HRQoL, safety, efficacy, and economical costs of using HER2DX in patients with stage II to IIIA HER2-positive breast cancer, suitable for neoadjuvant therapy. A dual primary endpoint with an according multiple testing procedure is defined in this study. First, the study will evaluate superiority in quality of life using i) the GHS scale from the EORTC QLQ-C30 questionnaire version 3.0 and ii) the score from the FACIT Fatigue Scale. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06446882
Study type Interventional
Source Fundacio Clinic Barcelona
Contact
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date November 2028
View Details
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