Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446882
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-27
Brief Title:
Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer
Sponsor:
Fundacio Clinic Barcelona
Organization:
Fundacio Clinic Barcelona
Study Overview
Official Title:
Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEFINITIVE
Brief 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 physicians choice blinded to the diagnostic HER2DX test results Patients randomized to Arm B will receive personalized treatment according to HER2DX results
Patients randomized to arm A will receive adjuvant treatment by physicians choice blinded to the diagnostic HER2DX test results Patients randomized to Arm B will receive personalized treatment according to HER2DX results
Detailed 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 30 and ii the score from the FACIT Fatigue Scale
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 30 and ii the score from the FACIT Fatigue Scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None