Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548178
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
T-DXd Versus THP for Medium-risk HER2-positive Early Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Trastuzumab Deruxtecan T-DXd Versus Standard Treatment for Medium-risk HER2-positive Early Breast Cancer a Randomized Multi-center Trial EXTEND
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study EXTEND trial is a multicentre interventional prospective randomised open-label controlled neoadjuvant phase 2 trial evaluating the efficacy and safety of T-DXd monotherapy vs standard-of-care docetaxel trastuzumab pertuzumab THP in medium-risk lymph node negative with a primary tumour stage T2 HER2-positive early breast cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None