NCT00328432已完成1 期
Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.
研究概览
简要总结
To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.
详细描述
A double blind randomized study of celecoxib 400 mg bid versus placebo in newly diagnosed breast cancer. Assessment of modulation of tissue markers (Ki-67, ER, VEGF, PR, etc.) and serum markers (estradiol, estrone, SHBG, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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
- •women with a recent diagnosis of T1 or T2 non-invasive breast cancer by large core needle or excisional biopsy
- •confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments
- •reexcision planned within 10 days to 6 weeks from study start
- •if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
排除标准
- •no hormone replacement therapy within the 90 days prior to biopsy
- •if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision
- •no evidence of metastatic malignancy of any kind
- •no history of asthma, allergy ASA, NSAIDS, celecoxib or other COX-2 inhibitors for a chronic non-oncological condition with the excision of low dose ASA (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study.
- •no celecoxib or rofecoxib use within one month of biopsy
- •no history of gastrointestinal ulcer or ulcerative colitis requiring treatment
- •no current anticoagulants
- •no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study
- •no aromatase inhibitor in the six months prior to participation
- •no concomitant lithium
- •no known significant bleeding disorder
结局指标
主要结局
Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.
次要结局
- Baseline and post-administration assessments of MAP kinase, pERK1 and 2, activated pAKT, change in apotosis indicators, and angiogenesis associated proteins, and Her-2/neu.
研究者
研究点 (14)
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