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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,600
Lyophilized powder injection, 100mg / bottle, intravenous drip
Lyophilized powder injection, 160mg / bottle, 100mg / bottle, intravenous drip
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGTianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGInvasive disease-free survival (IDFS)
Time frame: Randomization until the disease progressed, up to approximately 77 months postdose
Disease-free survival (DFS)
Time frame: Randomization until the disease progressed, up to approximately 77 months postdose
Overall survival(OS)
Time frame: Randomization until death from any cause, up to approximately 101 months postdose.
Distant recurrence-free interval (DRFI)
Time frame: Randomization until distant recurrence or death from any cause, up to approximately 101 months postdose.
Safety endpointPercentage of Adverse Events in Participants
Time frame: Baseline up to approximately 101 months postdose
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