This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Drug: SHR-A1811 Injection
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
RECRUITINGTotal pathological complete response (tpCR: ypT0-is/ypN0)
Time frame: At the time of surgery
Breast pathological complete response (bpCR:ypT0-is)
Time frame: At the time of surgery
Residual cancer burden (RCB)
Time frame: At the time of surgery
Best overall response rate (BORR)
Time frame: During 18 weeks of the neoadjuvant treatment
Overall survival (OS)
Time frame: 5 years
Disease-free survival (DFS)
Time frame: 5 years
Event-free survival (EFS)
Time frame: 5 years
Health-related quality of life (HRQOL) (EORTC QLQ-C30)
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30)
Time frame: During 18 weeks of the neoadjuvant treatment
Health-related quality of life (HRQOL)
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL
Time frame: During 18 weeks of the neoadjuvant treatment
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