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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

StatusActive, Not Recruiting
PhasePhase 3
Started2023-11-20
View on ClinicalTrials.gov ↗

Amendment history

2026-06-29
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 1600→confirmed 1615
Study sitesdetails revised at 2 of 2 sites
2025-04-29
notable
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-11-20
Enrollment target1200→1600
Study sites0→2
2023-11-07
minor
Original filing
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 Therapy,This 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 therapy.The 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).
Trial Details
NCT Number NCT06126640
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Enrollment 1,615 participants
Start Date 2023-11-20
Primary Completion 2030-04 (estimated)
Study Completion 2032-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-30