A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 62
- 主要终点
- Time to disease progression
研究概览
简要总结
The main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.
详细描述
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study comparing with pegylated liposomal doxorubicin (PLD) with capecitabine as first line chemotherapy of metastatic breast cancer in women 60 years and older. The study consists of a screening Phase (up to 14 days prior to treatment), treatment phase (up to 1 year), and post-treatment follow-up phase. The planned duration of treatment was 1 year in the absence of disease progression or unacceptable toxicity. Approximately 300 patients will be enrolled and randomly assigned to receive 1 of 2 treatment groups (PLD or capecitabine). Safety evaluations will consist of vital sign examination, physical examination, incidence and severity of adverse events, and laboratory tests findings and will be followed throughout the study.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically or pathologically proven metastatic breast cancer
- •Eastern Cooperative Oncology Group performance status between 0-2
- •Adequate bone marrow, renal and liver functions within normal limits
- •Left ventricular ejection fractions more than 45% measured by multiple gated acquisition scan or echocardiogram within 6 weeks of randomization
排除标准
- •Prior chemotherapy for metastatic disease (hormonal or chemotherapy in adjuvant setting and hormonal therapy in metastatic setting is allowed)
- •Prior treatment with capecitabine or pegylated liposomal doxorubicin in the adjuvant setting (prior anthracyclines up to certain dose limit is allowed)
- •Evidence of brain metastases unless previously treated and asymptomatic for 3 months or greater
- •History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
- •Anthracycline resistant disease (locally recurrent or metastatic disease while on adjuvant anthracycline therapy or relapse less than 18 months after therapy completion)
研究组 & 干预措施
Group 1 (doxorubicin)
Pegylated liposomal doxorubicin 40 mg/m2 administered intravenously on Day 1 of each cycle. Cycle is repeated every 28 days, up to one year.
干预措施: Pegylated liposomal doxorubicin (Drug)
Group 2 (capecitabine )
Capecitabine administered orally at a dosage of 2000 mg/m2/day (1000 mg/m2 BID) for 14 consecutive days followed by a 7-day rest period. Cycle is repeated every 21 days, up to one year.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Time to disease progression
时间窗: Up to disease progression or death
Time to disease progression is the duration in months from the date of randomization to the first documented evidence of disease progression or death caused by disease progression before the end of study. Time to disease progression will be compared between patients treated with doxorubicin and capecitabine.
次要结局
- Overall survival(Up to 2 years after last patient is enrolled or death)
- Overall Response rate(Up to disease progression or death)
- Number of patients with adverse events(Up to 1 month after intake of last dose of study medication)
- Subjective Significance Questionnaire (SSQ)(Day 1 and end of treatment)
- The European Organization for Research and Treatment of Cancer (EORTC) QLQ (Quality of Life Questionnaire) - C30(Day 1 and end of treatment)