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

VVOG0 个研究点目标入组 140 人开始时间: 2009年3月17日最近更新: 2015年8月17日

适应症

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•- 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

•- 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

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