NCT04246502尚未招募2 期
A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
Shandong Cancer Hospital and Institute0 个研究点目标入组 200 人开始时间: 2020年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab 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
干预措施: Capecitabine and Pyrotinib (Drug)
B
Active Comparator
干预措施: Capecitabine,Trastuzumab, and Pertuzumab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Approximately 42 months
次要结局
- Duration of Objective Response(Approximately 42 months)
- Adverse Events and Serious Adverse Events(From the first drug administration to within 28 days for the last treatment)
- Clinical Benefit rate(From the start of randomization to 6 months)
- Overall Survival(Up to 2 years)
- Objective Response Rate(Approximately 42 months)
研究者
Zhiyong Yu
Shandong Breast Disease Centre
Shandong Cancer Hospital and Institute
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