Open label, prospective observational, multi-center trial in postmenopausal, hormone receptor positive breast cancer patients treated with eithertamoxifen or an aromatase inhibitor. Examination of the predictive value of biological markers AEBS/mEH, active tamoxifen metabolites and TGF beta system for response and non response of tamoxifen treatment.
- Conditions
- C50Malignant neoplasm of breast
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 1285
Histopathologic confirmed diagnosis of breast cancer, stage TxNxM0, postmenopausal status, hormone responsive status (positive estrogen and/or progesteron receptors), clinically indicated completion of adequate surgery and chemotherapy, radiotherapy may be planned, planned adjuvant tamoxifen or aromatase inhibitor treatment for five years or planned switch of endocrine therapy provided Tamoxifen is given for at least 2 years, age > 18 years, performance status: ECOG < 2, written informed consent
Negative hormone receptor status, medical history of prior tamoxifen or aromatase inhibitor treatment, concurrent hormone substitution, suspected or confirmed poor compliance, other co-existing malignancies or malignancies diagnosed within the last 5 years, in the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable respiratory, cardiac, hepatic or renal disease) significantly compromising life expectancy.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method