临床试验/NCT01237327

NCT01237327已完成3 期

Follow-up of the Study 971-ONC-0028-080: Exemestane Versus Megestrol Acetate In Postmenopausal Patients With Metastatic Breast Cancer, Failing Anti-Estrogens: An Open-Label, Randomized, Parallel-Group, Phase III Comparative Study

Pfizer7 个研究点分布在 1 个国家目标入组 84 人开始时间: 2001年11月最近更新: 2011年5月6日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Pfizer
入组人数: 84
试验地点: 7
主要终点: Overall Survival

研究概览研究设计入排标准研究组 & 干预措施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

Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.

研究设计

研究类型: Interventional
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

性别: Female
接受健康志愿者: 否

入选标准

•Previous participation in study 971-ONC-0028-080.

排除标准

•Subjects who had not previously participated in study 971-ONC-0028-080.

研究组 & 干预措施

1

Active Comparator

干预措施: Megestrol acetate (Drug)

2

Experimental

干预措施: exemestane (Aromasin) (Drug)

结局指标

主要结局

Overall Survival

时间窗: Every 12 weeks up to 6 years

Overall survival in months measured from date of starting treatment in core study to date of death for any reason.

次要结局

Objective Response Rate (ORR)(Every 12 weeks up to 6 years)
Duration of Response (DR)(Every 12 weeks up to 6 years)
Time to Tumor Progression (TTP)(Every 12 weeks up to 6 years)
Time to Treatment Failure (TTF)(Every 12 weeks up to 6 years)

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (7)

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不适用

Tamoxifen and Exemestane Trial (TEXT)Premenopausal women with histologically proven, resected breast cancer with ERand/or PgR positive tumorsMedDRA version: 14.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2004-000168-28-SEInternational Breast Cancer Study Group (IBCSG)2,639