Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.

Pfizer1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2002年6月1日最近更新: 2012年2月16日

适应症

试验速览

阶段: 2 期
状态: 终止
发起方: Pfizer
入组人数: 100
试验地点: 1
主要终点: To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer.

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

The purpose of this study is to find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.

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 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•other diagnosed with breast cancer
•estrogen receptor positivity
•Postmenopausal status
•advanced disease
•progression to previous tamoxifen therapy

排除标准

•more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease
•previous hormonotherapy other than Tamoxifen

结局指标

主要结局

To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer.

次要结局

to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin
to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations
to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
to evaluate the efficacy (as tumor response)
to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation
to evaluate the effect on serum bone turnover markers

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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