A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 301
- 试验地点
- 67
- 主要终点
- Progression-free Survival (PFS) as Assessed by an IRC
研究概览
简要总结
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
RC48-ADC
Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
干预措施: RC48-ADC (Drug)
Lapatinib + Capecitabine
Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
干预措施: Lapatinib (Drug)
Lapatinib + Capecitabine
Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-free Survival (PFS) as Assessed by an IRC
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Tumor response was assessed by an IRC according to RECIST v1.1.
次要结局
- Progression-free Survival (PFS) as Assessed by Investigator(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Objective Response Rate （ORR）(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Duration of Objective Response (DOR)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Clinical Benefit Rate （CBR）(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Time to Treatment Failure(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Overall Survival(From date of randomization until the date of death from any cause, assessed up to 48 months)