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. MedDRA version: 14.0 Level: LLT Classification code 10006188 Term: Breast cancer female NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Tamoxifen
Product Name: Tamoxifen
Pharmaceutical Form: Tablet
CAS Number: 54965-24-1
Other descriptive name: TAMOXIFEN CITRATE
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
VVOG
Eligibility
Sex/Gender
All
Inclusion criteria
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. - 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
Exclusion criteria
Exclusion criteria: - Male - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: relation between metabolites concentrations and change in endometrial thickness or uterine volume (relation with oestrogen activity of the endometrium). ;Secondary Objective: tolerabiliy of tamoxifen predictive value of the tamoxifen activity score HRQoL Questionnary biochemical changes (FSH and SHBG) vaginal bleeding ;Primary end point(s): metabolite concentration after 6 months change in endometrial thickness or uterine volume ;Timepoint(s) of evaluation of this end point: 6 months after start with tamoxifen | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): FSH and SHBG concentration at 6 months single nucleotide polymorphisms in genes important for the metabolisation of tamoxifen;Timepoint(s) of evaluation of this end point: 6 months after start with tamoxifen | — |
Countries
Belgium
Contacts
Public ContactChantal Blomme
University Hospitals Leuven
Outcome results
None listed