SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1. Female patients aged ≥ 18 but ≤ 75 years 2. Histologically confirmed to be HR+/HER2-Low invasive breast cancer 3. Treatment-naive patients with stage II-III 4. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 5. Good level of organ function 6. Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits Exclusion Criteria: 1. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. Received any other anti-tumor therapy at the same time 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer 4. Stage IV breast cancer 5. Not confirmed by histopathology 6. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer 7. Participated in other drug clinical trials within 4 weeks before enrollment 8. Known allergic history of the d