Neoadjuvant Pyrotinib, Trastuzumab, Docetaxel Followed by Pertuzumab, Trastuzumab, Docetaxel Versus Pertuzumab, Trastuzumab, Docetaxel for the Treatment of Early or Locally Advanced HER2-Positive Breast Cancer: A Randomized, Multicenter, Open-Label Study
This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.
• Signed informed consent.
• Age: Female patients aged 18-70 years.
• Breast cancer meeting the following criteria:
‣ Histologically confirmed invasive breast cancer, with primary tumor diameter ≥ 2.0 cm, Stage II-III as assessed by local standard methods.
⁃ HER2-positive breast cancer, defined as Immunohistochemistry (IHC) score 3+ or In Situ Hybridization (ISH) showing HER2 gene amplification.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
• All required baseline laboratory tests and imaging studies completed before randomization.
• Adequate organ function
• For non-menopausal (amenorrhea \< 12 months) or non-surgically sterile female patients (without ovaries and/or uterus): Agreement to abstain or use reliable and effective contraception during treatment and for at least 6 months after the last dose of study treatment.
• Investigator judgment that the patient can comply with the study protocol.