NCT00072865已完成2 期
A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- antitumor activity
研究概览
简要总结
This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
- •No prior chemotherapy for locally advanced or metastatic breast disease.
- •Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
- •Adequate bone marrow, liver and kidney function
- •RECIST criteria for disease status
排除标准
- •Prior treatment with pemetrexed
- •Pregnant or breast feeding
- •Brain Metastasis
- •unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
结局指标
主要结局
antitumor activity
次要结局
- duration of response;time to progressive disease;time to treatment failure
研究者
研究点 (3)
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