This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
740
SHR-A1811 for injection.
Docetaxel injection.
Trastuzumab injection.
Carboplatin for injection.
Pertuzumab injection.
Shengjing Hospital, China Medical University
Shenyang, Liaoning, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPostoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments.
Time frame: From the enrollment of the first subject to the end of the study, it lasted about 36 months.
Postoperative total pathologic complete response (tpCR) evaluated pathologists at the research center after finishing neoadjuvant treatments.
Time frame: From the enrollment of the first subject to the end of the study, it lasted about 36 months.
Event-free survival (EFS).
Time frame: Followed up for at least 3 years.
Disease-free survival (DFS).
Time frame: Followed up for at least 3 years.
Distant disease-free survival (DDFS).
Time frame: Followed up for at least 3 years.
Objective response rate (ORR) assessed according to the preoperative evaluation utilizing RECIST v1.1 after finishing neoadjuvant treatments.
Time frame: Followed up for at least 3 years.
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