NCT03863223进行中（未招募）3 期
A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HER2 positive recurrent or metastasis breast cancer.
- •Patients with measurable disease are eligible.
- •Eastern Cooperative Oncology Group(ECOG) performance status 0 or
- •Adequate organ function.
- •Signed, written inform consent obtained prior to any study procedure.
排除标准
- •History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
- •History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
- •Assessed by the investigator to be unable receive systemic chemotherapy.
- •History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
- •Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
研究组 & 干预措施
A
Experimental
Pyrotinib Plus trastuzumab and docetaxel
干预措施: Pyrotinib, Trastuzumab, Docetaxel (Drug)
B
Placebo Comparator
Placebo plus trastuzumab and docetaxel
干预措施: Placebo, Trastuzumab, Docetaxel (Drug)
结局指标
主要结局
PFS
时间窗: Approximately 42 months
Progression Free Survival
次要结局
- AEs+SAEs(From the first drug administration to within 28 days for the last treatment)
- OS(Up to 2 years)
- ORR(Approximately 42 months)
- DoR(Approximately 42 months)
- CBR(From the start of randomization to 6 months)
研究者
研究点 (1)
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