A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

This is a single-arm, phase II trial evaluating the efficacy and safety of SHR-A1811 combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 and pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Inclusion Criteria:Female patients aged ≥ 18 but ≤ 75 yearsHistologically confirmed to be HER2-positive invasive breast cancerTreatment-naive patients with stage II-IIIEastern Cooperative Oncology Group (ECOG) score 0-1Good level of organ functionExclusion Criteria:Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)Received any other anti-tumor therapy at the same timeBilateral breast cancer, inflammatory breast cancer or occult breast cancerStage IV breast cancerWith a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancerInability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorptionParticipated in other drug clinical trials within 4 weeks before enrollmentHistory of allergies to the drug components of this protocolClinically significant pulmonary diseasesClinically significant cardiovascular diseasesHistory of immunodeficiencyActive hepatitis and liver cirrhosis