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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
182
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 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 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 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 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.
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGTotal 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.
Time frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
Secondary Outcome Measure
Breast pathological complete response is defined as the absence of residual invasive cancer in the breast after neoadjuvant therapy.
Time frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
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.
Time frame: At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation
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.
Time frame: From baseline to completion of neoadjuvant therapy, approximately 24 weeks
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.
Time frame: From enrollment to the first documented event or death, assessed up to 3 years
Distant Disease-Free Survival
Distant disease-free survival is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Time frame: From enrollment to distant metastasis or death, assessed up to 3 years
Overall Survival
Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive will be censored at the date of last follow-up.
Time frame: From enrollment to death from any cause, assessed up to 3 years
Number of Participants With Adverse Events
Safety will be assessed by the incidence and severity of adverse events, graded according to NCI CTCAE version 5.0.
Time frame: From the first dose of study treatment to 30 days after the last dose of neoadjuvant treatment
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