A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 With Herceptin as Neoadjuvant Treatment in Combination With Anthracycline/Paclitaxel Systemic Therapy in HER2-Positive Early Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 807
- 试验地点
- 89
- 主要终点
- Determination of pathologic complete response (pCR) at time of surgery
研究概览
简要总结
The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Bilateral breast cancer.
- •Pregnancy or lactation or considering becoming pregnant.
- •Metastases, other than sentinel/axillary lymph nodes.
- •Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for invasive malignant disease or other concomitant malignancy, other than basal cell carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed.
- •Previous treatment with Herceptin.
- •Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; history of myocardial infarction or cardiac failure, New York Heart Association (NYHA) class II or higher; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies; LVEF of <55%.
- •Any investigational treatment less than 30 days prior to study entry, or within a time interval less than at least 5 half-lives of the investigational medicinal product, whichever is longer.
- •Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- •History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
- •History of, or known current problems with, drug or alcohol abuse.
- •Other serious illness, medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.
研究组 & 干预措施
EG12014
Epirubicin and cyclophosphamide followed by EG12014 plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
干预措施: EG12014 (Drug)
Herceptin
Epirubicin and cyclophosphamide followed by Herceptin plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
干预措施: Herceptin (Drug)
结局指标
主要结局
Determination of pathologic complete response (pCR) at time of surgery
时间窗: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled sentinel and/or axillary lymph nodes
次要结局
- Incidence of AEs(From time of informed consent to end of study (up to approximately 25 months or death))
- Measure serum trastuzumab concentration(Prior to 1st infusion of study drug, during neoadjuvant treatment after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment)
- pCR at the time of surgery(At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy))
- Overall survival (OS) up to End of Study (EOS)(Randomization to end of study (up to approximately 24 months or death))
- Evaluation of Immunogenicity of EG12014 and Herceptin(Prior to 1st infusion of study drug, during neoadjuvant treatment, after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment)
- Event-free survival (EFS) up to end of study (EOS)(Randomization to date of progression or end of study (up to approximately 24 months or death))
- Overall response (OR) prior to surgery(At screening and prior to surgery (3-6 weeks after completion of neoadjuvant chemotherapy))