Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.
详细描述
The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Female, ≥ 18 and ≤ 70 years.
- •Histologically confirmed invasive breast cancer.
- •Metastatic breast cancer.
- •ECOG Performance Status of 0 to
- •Life expectancy of more than 3 months.
- •Subject must have adequate organ function.
- •Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 80×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN.
- •Negative serum pregnancy test for women with childbearing potential.
- •Good conditions for infusion and willing to have phlebotomy throughout whole study.
- •Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
- •Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
排除标准
- •Pregnant or lactating females
- •History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
- •Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
- •Active or uncontrolled infection
- •Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
- •Concomitant with brain metastases
- •Have received chemotherapy after metastasis
研究组 & 干预措施
combination chemotherapy
Simultaneous use of Vinorelbine and Capecitabine
干预措施: Vinorelbine and Capecitabine (Drug)
sequential chemotherapy
Sequential use of Vinorelbine and Capecitabine
干预措施: Vinorelbine and Capecitabine (Drug)
结局指标
主要结局
PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)
时间窗: Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.
次要结局
- TTP(time to progression) and OS (overall survival)(TTP and OS were assessed every cycle and during the follow up time, until the event occurs.)
- Safety, QOL(quality of life)(Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle.)