ctDNA in HER2+ EBC Neoadjuvant Treatment

A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer

This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy

Inclusion Criteria:

• histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter >2cm)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
• No prior treatment

Exclusion Criteria:

• Bilateral or metastatic breast cancer
• History of other malignancies
• Severe cardiovascular disease
• Allergic to any of the regimens