About this trial
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.
Eligibility criteria
Qualifiers
Female patients aged ≥ 18 but ≤ 75 years
Histologically confirmed to be HR+/HER2-Low invasive breast cancer
Treatment-naive patients with stage II-III
Eastern Cooperative Oncology Group (ECOG) score is 0 or 1
Disqualifiers
Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
Received any other anti-tumor therapy at the same time
Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
Stage IV breast cancer
Trial design
Treatments tested in this trial
- SHR-A1811 Injection + Adebrelimab Injection
- SHR-A1811 Injection + Adebrelimab Injection
- SHR-A1811 Injection
Treatment groups
Sponsors and collaborators
Shengjing Hospital
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator