NCT00810706终止3 期
A Phase III Randomized Parallel-Group Multicenter Trial, Designed to Compare 5 Years of Adjuvant Exemestane Versus 5 Years of Observation in Postmenopausal Women With Operable Breast Cancer Who Have Received 5-7 Years of Adjuvant Tamoxifen.
Hellenic Breast Surgeons Society1 个研究点 分布在 1 个国家目标入组 448 人开始时间: 2001年4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
- 终止
- 发起方
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
The ATENA phase III randomized parallel-group multicenter trial is designed to compare 5 years of adjuvant exemestane versus 5 years of observation in postmenopausal women with operable breast cancer who have received 5-7 years of adjuvant tamoxifen. The primary endpoint for the core protocol is disease-free survival (DFS). Exemestane treatment is planned for 5 years unless disease relapse or excessive toxicity is documented, the patient refuses further treatment or any new anti-cancer therapy is initiated.
详细描述
- Patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry.
- A substudy (ATENA lipid substudy)is designed to evaluate changes in the patients' serum lipid profile during study treatment.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women only
- •histologically confirmed stage I-IIIA primary adenocarcinoma of the breast
- •estrogen and/or progesterone receptors positive or unknown
- •patients should have undergone surgery with a curative intent
- •patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry
- •Absence of any evidence of local or distant metastatic disease was required prior to randomization
排除标准
- •DCIS, bilateral breast cancer, evidence of metastasis, ER and Pgr negative
研究组 & 干预措施
2: Exemestane
Active Comparator
Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment
干预措施: exemestane (Drug)
结局指标
主要结局
DFS
时间窗: 5 years
次要结局
- effect of exemestane on lipaemic profile(2 years)
研究者
研究点 (1)
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