A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 809
- 试验地点
- 146
- 主要终点
- Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
研究概览
简要总结
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).
- •Available tumor tissue for central review of HER2 status.
- •Planned surgical resection of breast tumor.
- •Planned neoadjuvant chemotherapy.
- •Documentation of HER2 gene amplification or overexpression.
- •Ipsilateral, measurable tumor longest diameter > 2 cm.
- •Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).
- •ECOG performance status of 0 or
- •Adequate bone marrow, hepatic and renal functions.
- •Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.
- •Effective contraception as defined by protocol.
排除标准
- •Investigational therapy within 2 months of first dose of study drug.
- •Bilateral breast cancer.
- •Inflammatory breast cancer
- •Metastases.
- •Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.
- •Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.
- •Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.
- •Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.
- •Pre-existing clinically significant Grade 2 peripheral neuropathy.
- •Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).
- •Severe dyspnea at rest requiring oxygen therapy.
- •Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C.
- •Current pregnancy or breastfeeding.
- •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.
研究组 & 干预措施
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: TX05 (trastuzumab) (Biological)
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: Paclitaxel (Drug)
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: Epirubicin (Drug)
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: Cyclophosphamide (Drug)
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: Herceptin® (Biological)
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: Paclitaxel (Drug)
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: Epirubicin (Drug)
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles
Followed by:
• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
时间窗: 3-7 weeks following last dose of study treatment
Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).
次要结局
- Objective Response Rate (ORR)(End of Treatment (Week 24) or Early Termination Visit)