EUCTR2009-010059-28-BE进行中（未招募）不适用
Addition to main protocol Leiden CYPTAM for Belgian centres onlyProtocol outline – CYP-TAMBRUT-3Prevalence of genetic polymorphisms in genes coding for tamoxifen metabolising enzymes, in postmenopausal ER-positive breast cancer patients according to uterine and biochemical changes and tolerability of tamoxifen. - CYPTAMBRUT-3
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- VVOG
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Female > 18 years of age
- •- Written and voluntary informed consent understood signed and dated
- •- Histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast, amenable to curative therapy.
- •- Patients must be postmenopausal as defined by criteria in appendix 1.
- •- Breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
- •- Prior endocrine tamoxifen therapy is not allowed
- •- Patients are not previously treated with an endocrine agent or hormone replacement therapy.
- •- Prior chemotherapy and radiotherapy is allowed
- •- Adequate renal and liver function
- •Serum creatinine and serum bilirubine = 1.5 X ULN
- •Serum ALT and AST = 2.5 X ULN (or = 5 in case of liver metastases)
- •- Serum calcium should be = 11,6 mg/dl
- •- ECOG performance status 0,1,2 (appendix 2)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
- •- Use of any endocrine treatment or hormone replacement therapy.
- •- Contra indication for tamoxifen: history of DVT/vaginal bleeding of unknown origin
- •- Dementia
- •- History of other malignancy that may interfere with at least 6 months of tamoxifen therapy
研究者
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