A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer

Eli Lilly and Company3 个研究点分布在 2 个国家目标入组 50 人开始时间: 2003年6月最近更新: 2007年1月26日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 50
试验地点: 3
主要终点: antitumor activity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

Eli Lilly and Company

申办方类型

Industry

研究点 (3)

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