Pharmacokinetics Study of Combined Treatment Lapatinib and Tamoxifen in Advanced/Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination
研究概览
简要总结
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving lapatinib together with tamoxifen may be an effective treatment for breast cancer.
PURPOSE: This randomized phase I trial is studying the side effects of lapatinib and tamoxifen in treating patients with advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the pharmacokinetics of lapatinib ditosylate and tamoxifen citrate in patients with advanced or metastatic breast cancer.
Secondary
- Assess the safety of this regimen in these patients.
- Determine any relationship between drug exposure and adverse events or biological modifications of this regimen in these patients.
- Assess the antitumor activity of this regimen in patients with measurable 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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tamoxifen-lapatinib
Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.
干预措施: lapatinib ditosylate (Drug)
Tamoxifen-lapatinib
Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.
干预措施: tamoxifen citrate (Drug)
Tamoxifen-lapatinib
Tamoxifen alone at cycle 1 and as of cycle 2 in combination with Lapatinib.
干预措施: pharmacological study (Other)
Lapatinib-tamoxifen
Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen
干预措施: lapatinib ditosylate (Drug)
Lapatinib-tamoxifen
Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen
干预措施: tamoxifen citrate (Drug)
Lapatinib-tamoxifen
Lapatinib will be given alone for 2 weeks during cycle 1. As of cycle 2, you will receive the combined treatment Lapatinib and Tamoxifen
干预措施: pharmacological study (Other)
结局指标
主要结局
Pharmacokinetic profile of lapatinib ditosylate and tamoxifen citrate alone and in combination
时间窗: maximum 24h after the dose administered on Day 28
次要结局
- Safety(until disease progression or until the start of another treatment (average 2 months))
- Relationship between drug exposure and adverse events or biological modifications(until disease progression or until the start of another treatment (average 2 months))
- Response in patients with measurable disease(until disease progression or until the start of another treatment (average 2 months))