ISRCTN09768535已完成3 期
eoadjuvant trial of pre-operative exemestane or letrozole +/- celecoxib in the treatment of oestrogen receptor-positive early breast cancer
niversity Hospital Birmingham NHS Foundation Trust (UK)0 个研究点目标入组 269 人开始时间: 2006年7月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 269
研究概览
简要总结
2016 Abstract results in https://doi.org/10.1158/1538-7445.SABCS15-PD2-02 (added 02/03/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Biopsy proven
- •2. ER positive invasive breast cancer (where ER positive is defined as equivalent to an ER Quick or Allred score of 3 or greater)
- •3. Tumour, measured on clinical examination, as greater than 2 cm in diameter
- •4. Postmenopausal
- •5. Adequate haematological, renal and liver function, defined as: platelets of greater than 100 x 10(9)/l, white blood cell count of greater than 3 x 10(9)/l, creatinine less than 110 mmol/l, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) less than 1.25 x upper limit of normal
- •6. Patients must be fit to complete surgery for their breast cancer
- •7. Written informed consent
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2
排除标准
- •1. Bilateral breast cancer
- •2. Evidence of distant metastases (M1)
- •3. Patients who have received previous treatment for breast cancer
- •4. Concomitant active malignancy except for adequately treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
- •5. Co-morbid disease which would preclude safe surgical treatment of the primary cancer
- •6. Other physical or psychiatric disorder that may interfere with subject compliance, adequate informed consent or determine the causality of adverse events
- •7. Contraindications to celecoxib: active peptic ulcer disease, renal impairment, asthma exacerbated by non steroidal anti-inflammatory drugs (NSAIDs), congestive cardiac failure (New York Heart Association [NYHA II-IV]), ischaemic heart disease, cerebrovascular disease, uncontrolled hypertension
- •8. Patients with an ongoing requirement for regular NSAID or COX-2 inhibitor therapy (asprin 75 mg daily is permitted)
- •9. Regular selective COX-2 inhibitor use in the two years prior to randomisation
- •10. History of hypersensitivity to celecoxib, exemestane or letrozole or to any of the excipients
- •11. Known hypersensitivity to sulphonamides
- •12. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 inhibitors
- •13. Inflammatory bowel disease
- •14. Patients with ongoing requirements for fluconazole or ketoconazole therapy
- •15. Patients with ongoing requirement for lithium therapy
- •16. Patients with ongoing requirement for angiotensin-converting enzyme (ACE) inhibitor therapy
- •17. Patients who are anticoagulated
研究者
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