This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer.
Eligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.
Female patients aged 18 to 65 years.
Patients with previously untreated invasive breast cancer confirmed by pathological examination.
HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.
Clinical stage T2N0-3M0 or any T/N1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.
Concurrent receipt of any other anti-tumor therapy.
Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
Stage IV breast cancer.
Single group
Pyrotinib Maleate
DrugPyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. It should be taken within 30 minutes after breakfast and continued throughout the neoadjuvant treatment period.
Trastuzumab (H, 8mg/kg
DrugTrastuzumab will be administered intravenously at a loading dose of 8 mg/kg on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent 3-week cycle during neoadjuvant treatment.
pegylated liposomal doxorubicin hydrochloride
DrugPegylated liposomal doxorubicin hydrochloride will be administered intravenously at 35 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment.
Cyclophosphamide
DrugCyclophosphamide will be administered intravenously at 600 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment in combination with pegylated liposomal doxorubicin hydrochloride, pyrotinib, and trastuzumab.
Paclitaxel for Injection Albumin Bound
DrugPaclitaxel for injection albumin bound will be administered intravenously at 230-260 mg/m² on Day 1 of each 3-week cycle for the subsequent 4 cycles of neoadjuvant treatment in combination with pyrotinib and trastuzumab.
Total Pathological Complete Response Rate
Total pathological complete response is defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes after neoadjuvant therapy.
Secondary Outcome Measure
Breast pathological complete response is defined as the absence of residual invasive cancer in the breast after neoadjuvant therapy.
Lymph Node Pathological Complete Response Rate
Lymph node pathological complete response is defined as the absence of residual invasive cancer in axillary lymph nodes after neoadjuvant therapy.
Objective Response Rate
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST version 1.1 during neoadjuvant therapy.
Event-Free Survival
Event-free survival is defined as the time from enrollment to disease progression, recurrence, distant metastasis, second primary malignancy, or death from any cause, whichever occurs first.
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