Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- whole-genome expression after celecoxib treatment
研究概览
简要总结
Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor celecoxib.
In a single-centre double-blinded phase II study, breast cancer patients were randomised to receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray, which allows to study the genome-wide changes at the transcriptional level.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients suspected of having invasive breast cancer, >1 cm in diameter, and in whom there is an indication for a core or incision biopsy
- •Age <75 years at time of diagnosis
- •Patient willing and able to comply with the study prescriptions
- •Patient able to give written informed consent before patient registration/randomisation
- •Pre- and post-menopausal patients are eligible
- •Hormone receptor positive and negative patients are eligible
- •A negative pregnancy test in pre-menopausal women
排除标准
- •HIV, HBV or HCV positivity
- •Known hypersensitivity to NSAIDs
- •A history of upper gastro-intestinal bleeding
- •Endoscopically proven upper gastro-intestinal ulceration
- •Patients using NSAIDs, including salicyclic acid
- •Systemic use of corticosteroids
- •A history or the presence of any other malignancy excepting adequately treated squamous cell skin cancer or in situ carcinoma of the cervix
- •Patients who have been treated with neo-adjuvant chemotherapy or hormone therapy
研究组 & 干预措施
placebo
pre-operative placebo twice daily for two to three weeks
干预措施: Placebo (Drug)
celecoxib
pre-operative celecoxib (400 mg) twice daily for two to three weeks
干预措施: celecoxib (Drug)
结局指标
主要结局
whole-genome expression after celecoxib treatment
Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues
次要结局
- Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues