Viewing Study NCT06126640



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