Status:
COMPLETED
Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes
Lead Sponsor:
Vlaamse Vereniging voor Obstetrie en Gynaecologie
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Brief Summary
CYPTAM-BRUT 3 is a prospective, multicentric study in Belgium within the CYPTAM study of the Leiden University Medical Center (NTR1509) including postmenopausal women receiving tamoxifen for estrogen-...
Detailed Description
We will study the impact of the 'tamoxifen activity score' - based on functional genetic polymorphisms for tamoxifen metabolism and the use of drugs that interfere with tamoxifen-against tamoxifen rel...
Eligibility Criteria
Inclusion
- 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 needs being stopped for at least 6 months.
- Prior chemotherapy and radiotherapy is allowed
- Adequate renal and liver function Serum creatinine and serum bilirubin ≤ 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)
Exclusion
- Male
- Life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
- Use of any endocrine treatment or recent/current use of 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00966043
Start Date
June 1 2009
End Date
July 1 2011
Last Update
October 28 2015
Active Locations (11)
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1
AZ St-Maarten
Duffel, Antwerpen, Belgium, 2570
2
AZ St-Nikolaas
St-Niklaas, Antwerpen, Belgium, 9100
3
Ziekenhuizen Oost-Limburg Camus St-Jan
Genk, Limburg, Belgium, 3600
4
AZ St-Blasius
Dendermonde, Ookst-Vlaanderen, Belgium, 9200