NCT06126640View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,600

Participants

Timeline

Start Date

November 20, 2023

Primary Completion Date

April 30, 2030

Study Completion Date

April 30, 2032

Conditions
HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Interventions
DRUG

SHR-A1811

Lyophilized powder injection, 100mg / bottle, intravenous drip

DRUG

Trastuzumab Emtansine

Lyophilized powder injection, 160mg / bottle, 100mg / bottle, intravenous drip

Trial Locations (2)

200030

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

300060

RECRUITING

Tianjin Medical University Cancer Institute & Hospital, Tianjin

All Listed Sponsors
lead

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY