Clinical trial · Observational
Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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-receptor positive breast cancer in the adjuvant setting. The primary endpoint is the difference in uterine changes between women with a normal versus low TAS after 3 months of tamoxifen use. Secondary endpoints are serum metabolite concentrations, serum follicle-stimulating hormone level, serum sex hormone-binding globulin level and menopausal symptoms. These patients are registered in the Leiden protocol with time to breast cancer event as primary endpoint.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- change in endometrial thickness or uterine volume
- timeFrame
- 3-6 months
Secondary outcomes (3)
- measure
- Tolerability of tamoxifen-HRQoL questionnaire
- timeFrame
- 3-6 months
- measure
- Vaginal bleeding
- timeFrame
- 3-6 months
- measure
- Biochemical changes
- timeFrame
- 3-6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available