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

• Status: Not yet recruiting
• Trial end date: 2028-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shengjing Hospital
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• Female patients aged ≥ 18 but ≤ 75 years

• Histologically confirmed to be HER2-positive invasive breast cancer

• Treatment-naive patients with stage II-III

• Eastern Cooperative Oncology Group (ECOG) score 0-1

• Good level of organ function

Exclusion Criteria:

• Previously received 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

• With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer

• Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption

• Participated in other drug clinical trials within 4 weeks before enrollment

• History of allergies to the drug components of this protocol

• Clinically significant pulmonary diseases

• Clinically significant cardiovascular diseases

• History of immunodeficiency

• Active hepatitis and liver cirrhosis