Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT07635342
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrotinib Maleate — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

First listed
Jun 9, 2026
Start date
Apr 30, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
182 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy
    Participants will receive 8 cycles of neoadjuvant treatment. Pyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. Trastuzumab will be administered intravenously at a loading dose of 8 mg/kg in Cycle 1, followed by 6 mg/kg on Day 1 of each 3-week cycle. During the first 4 cycles, participants will receive pegylated liposomal doxorubicin hydrochloride 35 mg/m² and cyclophosphamide 600 mg/m² intravenously on Day 1 of each 3-week cycle. During the subsequent 4 cycles, participants will receive paclitaxel for injection albumin bound 230-260 mg/m² intravenously on Day 1 of each 3-week cycle.

Primary Outcome Measure

Total Pathological Complete Response Rate [ Time Frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation ]

Central Contacts

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