Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.
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
- •Histologically confirmed metastatic breast cancer
- •Disease progression during or after previous 1st line chemotherapy
- •Scheduled to receive 2nd line chemotherapy.
- •Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
- •18 years of age or older
- •ECOG performance status of 0-2
- •Life expectancy of greater than 6 months
排除标准
- •Previous treatment with one of the study drugs
- •Application of other cytotoxic chemotherapy or radiotherapy
- •Insufficent renal function (creatinine clearance < 60ml/min)
- •Clinically unstable brain metastasis
- •Pregancy or lactation
- •History of other malignancy within last 5 years.
研究组 & 干预措施
lobaplatin
gemcitabine plus lobaplatin
干预措施: lobaplatin (Drug)
cisplatin
gemcitabine plus cisplatin
干预措施: cisplatin (Drug)
结局指标
主要结局
Overall response rate
时间窗: 4 weeks after chemotherapy
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
次要结局
- Time to progression(one year after last patient in)
- Overall Survival(one year after last patient in)
- Treatment related toxicity(4 weeks after chemotherapy)
研究者
Qingyuan Zhang
Vice president of Cancer Hospital of Harbin Medical University
Harbin Medical University