Condition: Early-stage or Locally Advanced HER2-positive Breast Cancer · Sponsor: Jiangsu HengRui Medicine Co., Ltd.
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.
This description comes directly from the study's public registry record.
Yang Wu · +86-0518-82342973 · yang.wu.yw96@hengrui.com
Always discuss trial participation with your own doctor first.
| Shengjing Hospital, China Medical University | Shenyang, Liaoning, China | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07196774