The influence of genetic variations on uterine and biochemical changes in breast cancer patients receiving tamoxifen.

Conditions: 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: 14.0Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-010059-28-BE

Lead Sponsor: VVOG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 140

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: relation between metabolites concentrations and change in endometrial thickness or uterine volume (relation with oestrogen activity of the endometrium).<br>;Secondary Objective: tolerabiliy of tamoxifen<br>predictive value of the tamoxifen activity score<br>HRQoL Questionnary<br>biochemical changes (FSH and SHBG)<br>vaginal bleeding <br>;Primary end point(s): metabolite concentration after 6 months<br><br>change in endometrial thickness or uterine volume <br>;Timepoint(s) of evaluation of this end point: 6 months after start with tamoxifen

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): FSH and SHBG concentration at 6 months<br><br>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