Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126640
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-07
Brief Title:
A Phase III Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine T-DM1 in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Phase III Multicenter Randomized Open-Label Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine T-DM1 in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine T-DM1 in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant TherapyThis study will examine SHR-A1811versus trastuzumab emtansine T-DM1 in patients with HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes after neoadjuvant therapyThe primary objective is to compare invasive disease-free survival IDFS between SHR-A1811 and T-DM1 treatment arms in this population The key secondary objective of the study is to evaluate disease-free survival DFS overall survival OS and distant recurrence-free interval DRFI
Detailed Description:
None
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