Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Pyrotinib Maleate: Pyrotinib 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: Trastuzumab 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: Pegylated 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: Cyclophosphamide 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: Paclitaxel 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Total Pathological Complete Response Rate — At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Total pathological complete response is defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes after neoadjuvant therapy.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
More Hebei Medical University Fourth Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07635342 on ClinicalTrials.gov ↗ ← All trials in China