NCT00038103已完成2 期
Open-Label, Multicentre, Controlled Study Of Exemestane (Aromasin®) With Or Without Celecoxib (Celebrex®) In Postmenopausal Women With Advanced Breast Cancer (ABC) Having Progressed On Tamoxifen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Number of Subjects With Clinical Benefit
研究概览
简要总结
This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen.
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
- •Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.
- •Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.
- •at least one measurable lesion
排除标准
- •More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.
- •Previous hormonotherapy for advanced disease other than Tamoxifen.
- •Myocardial infarction within previous 6 mo
研究组 & 干预措施
1.
Active Comparator
干预措施: Exemestane (Drug)
2.
Experimental
干预措施: Celecoxib + Exemestane (Drug)
结局指标
主要结局
Number of Subjects With Clinical Benefit
时间窗: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)
Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.
次要结局
- Number of Subjects With Objective Response(Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV)
- Duration of Clinical Benefit(Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV)
- Duration of Objective Response (in Subjects With CR or PR)(Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV)
- Duration of Long-Term SD(Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV)
- Time to Tumor Progression(Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV)
- Time to Treatment Failure(Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV)
- Survival(Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death)
研究者
研究点 (1)
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