- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966043
Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes (CYPTAMBRUT-3)
Prevalence 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.
Study Overview
Status
Conditions
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 related endpoints like uterine changes and subjective menopausal symptoms.
The prevalence of genetic polymorphisms in the CYP2D6 and other genes and differences in usage of drugs interacting with tamoxifen metabolism will be compared between women with and those without endometrial thickening on one hand and between women with and those without hot flashes on the other hand. Tamoxifen use in adjuvant setting.
- "Tamoxifen activity score" (23): The endpoints will be correlated with a predefined 'tamoxifen activity score' which is based on the presence of single nucleotide polymorphisms (SNP) in relevant genes combined with the effect of well known drugs that interfere with the metabolism of tamoxifen. The 'tamoxifen activity score' has been associated with tamoxifen compliance by a group in the US (23). The score will be adapted to the Belgian situation based on the prevalence of these SNPs in a Belgian population of volunteers for blood donation and consecutive breast cancer patients.
- The study setting are postmenopausal women with an early ER- positive breast cancer and not previously treated with an endocrine agent or hormone replacement therapy, with an intact uterus and clearly measurable thin endometrium/uterus. N =250
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussel, Belgium, 1000
- Institut Bordet
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Brussel, Belgium, 1200
- UCL
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Brussel, Belgium, 1090
- UZ
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Antwerpen
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Duffel, Antwerpen, Belgium, 2570
- AZ St-Maarten
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St-Niklaas, Antwerpen, Belgium, 9100
- AZ St-Nikolaas
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Limburg
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Genk, Limburg, Belgium, 3600
- Ziekenhuizen Oost-Limburg Camus St-Jan
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Ookst-Vlaanderen
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Dendermonde, Ookst-Vlaanderen, Belgium, 9200
- AZ St-Blasius
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Oost-Vlaanderen
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Gent, Oost-Vlaanderen, Belgium, 9000
- Maria-Middelares
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Gent, Oost-Vlaanderen, Belgium, 9000
- UZ
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- UZ
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West-Vlaanderen
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Roeselare, West-Vlaanderen, Belgium, 8800
- Heilig-Hart Ziekenhuis
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in endometrial thickness or uterine volume
Time Frame: 3-6 months
|
3-6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tolerability of tamoxifen-HRQoL questionnaire
Time Frame: 3-6 months
|
3-6 months
|
Vaginal bleeding
Time Frame: 3-6 months
|
3-6 months
|
Biochemical changes
Time Frame: 3-6 months
|
3-6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick Neven, UZ Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eudract 2009-010059-28.
- S 51521
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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