A Double-blind, Randomised, Parallel Group, Phase III Study to Demonstrate Equivalent Efficacy and Comparable Safety of CT-P6 and Herceptin, Both in Combination With Paclitaxel, in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of the study is to demonstrate equivalence
详细描述
Patients will receive CT-P6 or Herceptin every 3 weeks.
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
- Triple (Participant, Care Provider, 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
- •Are females
- •Have Her 2 over-expression
- •Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •Current clinical or radiographic evidence central nervous system (CNS) metastases
- •Current Known infection
- •Pregnant or nursing mother
研究组 & 干预措施
CT-P6 & Paclitaxel
CT-P6 was administered at a loading dose of 8 mg/kg body weight by intravenous (IV) infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation.
Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation.
干预措施: CT-P6 (Drug)
CT-P6 & Paclitaxel
CT-P6 was administered at a loading dose of 8 mg/kg body weight by intravenous (IV) infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation.
Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation.
干预措施: Paclitaxel (Drug)
Herceptin & Paclitaxel
Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation.
Paclitaxel was administered at a dose of 175 mg/m2 BSA as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation.
干预措施: Herceptin (Drug)
Herceptin & Paclitaxel
Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation.
Paclitaxel was administered at a dose of 175 mg/m2 BSA as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 6 months (up to 24 weeks)
Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the number of patients in the corresponding population, as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1.
次要结局
- Time to Response(Through study completion, approximately 40 months)
- Progression Free Survival(Through study completion, approximately 40 months)
- Overall Survival(Through study completion, approximately 40 months)
- Safety Endpoints; Cardiotoxicity(Through study completion, approximately 40 months)
- Time to Progression(Through study completion, approximately 40 months)
- Safety Endpoints; Immunogenicity(During treatment, median of 13 cycles (every cycle is 3 weeks))
- Pharmacokinetic Endpoints; Ctroughss(predose and at 1.5 hours (end of infusion) of each cycle)