NCT00191815已完成2 期
Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Objective Tumor Response
研究概览
简要总结
The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •You are female in the age of 18 to 75 years old.
- •You have been diagnosed with the metastatic breast cancer.
- •You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
- •You must sign this informed consent form
排除标准
- •You are pregnant or breastfeeding.
- •Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
- •You have been diagnosed with serious concomitant or acute infectious disease.
- •You have used experimental medications within the last month.
研究组 & 干预措施
Gemcitabine + Cisplatin
Experimental
干预措施: Gemcitabine (Drug)
Gemcitabine + Cisplatin
Experimental
干预措施: cisplatin (Drug)
结局指标
主要结局
Objective Tumor Response
时间窗: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)
Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
次要结局
- Duration of Response(first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.))
- Time to Progressive Disease(first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.))
- Time to Treatment Failure(first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.))
- Survival Time(first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.))
- Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination(Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy))
- Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades(Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy))
- Number of Deaths(Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.))
- Number of Participants With Adverse Events Leading to Discontinuation(Baseline through eight 21-day cycles)
研究者
研究点 (1)
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