NCT00649090已完成4 期
A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,549
- 试验地点
- 1
- 主要终点
- Assess for serious adverse events
研究概览
简要总结
The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal patients
- •Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
- •Estrogen receptor positive breast cancer patients
- •Patients who remain free from disease following treatment with tamoxifen
排除标准
- •Patients taking other drugs for the adjuvant treatment of breast cancer
- •Patients taking hormone replacement therapy
- •Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
研究组 & 干预措施
Exemestane group
Active Comparator
干预措施: exemestane (Drug)
结局指标
主要结局
Assess for serious adverse events
时间窗: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment
次要结局
- Safety Surveillance Program(Duration of trial)
研究者
研究点 (1)
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