About this trial
It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.
Eligibility criteria
Qualifiers
Pathologically confirmed invasive triple negative breast cancer.
Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.
Previous neoadjuvant therapy must meet the requirements of the protocol.
Has received radical surgery for breast cancer.
Disqualifiers
Stage IV metastatic breast cancer.
Previous invasive breast cancer or ductal carcinoma in situ.
Bilateral breast cancer.
Any clinical evidence indicating the exist of recurrent diseases after surgery.
Trial design
Treatments tested in this trial
- Trastuzumab Rezetecan for Injection
- Adebrelimab Injection
- Capecitabine tablets
- Pembrolizumab injection
Treatment groups
Locations
1Sponsors and collaborators
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Lead sponsor