Pyrotinib Combined With Epirubicin and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab in Neoadjuvant Therapy of HER2-positive Early Breast Cancer: a Single-arm, Open-label, Multicenter Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- tpCR
研究概览
简要总结
This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer patients at the age of >= 18 years and <= 70 years who received first treatment；
- •Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)；
- •According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm；
- •The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1；
- •The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%;
- •Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug;
- •A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
排除标准
- •Known history of hypersensitivity to pyrotinib or any of it components;
- •Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured);
- •Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered;
- •Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption;
- •Patients with severe heart disease or discomfort who cannot be treated;
- •The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate;
- •Pregnant or lactating women;
- •Less than 4 weeks from the last clinical trial;
- •Patients participating in other clinical trials at the same time
- •The researchers think inappropriate.
研究组 & 干预措施
Experimental group
Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib
干预措施: Pyrotinib (Drug)
Experimental group
Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib
干预措施: Epirubicin (Drug)
Experimental group
Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib
干预措施: Cyclophosphamide (Drug)
Experimental group
Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib
干预措施: Taxanes (Drug)
Experimental group
Patients will receive the test drug (Pyrotinib) combined with Epirubicin and Cyclophosphamide followed by Taxanes and Trastuzumab with Pyrotinib
干预措施: Trastuzumab (Biological)
结局指标
主要结局
tpCR
时间窗: immediately after surgery
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
次要结局
- Objective Response Rate(ORR)(2 years)
- Disease-free survival(DFS) Baseline to measured date of recurrence or death from any cause(3 years)
- bpCR(immediately after surgery)
- Adverse Events rate(1-year)
研究者
Liu Yunjiang
Director
Hebei Medical University Fourth Hospital