NCT00525096已完成3 期
A Multicenter Randomized Phase III, Double-blind Study Comparing Efficacy of the Association of Exemestane and Celecoxib Versus Exemestane and Placebo in Menopausal Patients With Metastatic Breast Cancer.
ARCAGY/ GINECO GROUP0 个研究点目标入组 157 人开始时间: 2003年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 主要终点
- Progression free survival
研究概览
简要总结
To discover if the adding of a coxib increases the efficacy of the Aromasine.
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
- Double (Participant, Investigator)
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
- •Femal patient aged > 18 years
- •Histologically proven breast cancer
- •Menopausal patient according to the following definition:
- •amenorrhoea > 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin
- •surgical ovariectomy
- •treatment by LHRH analog
- •ovarian suppression by radiotherapy
- •amenorrhoea induced by chemotherapy > 1 year
- •Oestradiol and/or progesterone positive receptors
- •Presence of one or several metastatic lesion:
- •mesurable lesion
- •bone metastase were detected by bone scintigraphy
- •Patient who can have received:
- •Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen)
- •Metastatic Treatment by chemotherapy
- •Adequate biological values
- •Patient who has clearly given her consent by signing on informed consent form prior to participation
排除标准
- •Patient previously treated with hormonotherapy in metastatic phase
- •Antecedent of treatment with aromatase inhibitors
- •local relapse (with the exception of cutaneous thoracic nodes)
- •Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa
研究组 & 干预措施
Placebo
Placebo Comparator
Aromasin + placebo in place of Celebrex
干预措施: placebo (Drug)
Placebo
Placebo Comparator
Aromasin + placebo in place of Celebrex
干预措施: Exemestane (Drug)
Celebrex
Experimental
Aromasin + Celebrex
干预措施: Celecoxib (Drug)
Celebrex
Experimental
Aromasin + Celebrex
干预措施: Exemestane (Drug)
结局指标
主要结局
Progression free survival
时间窗: 5 years
次要结局
- Quality Of Life + pain(6 months)
- Overall survival(5 years)
- Tolerance(6 months)
- Objective response rate(6 months)
研究者
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