C50
Conditions
Interventions
Group 1: 20 mg commercially available tamoxifen, oral tablet, once daily.
Group 2: Commercially available aromataseinhibitor, oral ,tablet once daily, dose depending on choice of aromataseinhibitor (
Sponsors
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival within an observation period of 5 years in all patients expressing high versus low AEBS/mEH in breast tumour tissue. Measurements will be assessed in plasma and tumour tissues en block at the end of trial period ( 5 years). | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival with an observation period of 5 years in patients taking tamoxifen with high versus low plasma levels of active tamoxifen metabolites, impact of concomitant medication on formation of active tamoxifen metabolites, disease free survival in all patients with an increase of TGFß2 plasma levels versus no change in TGFß2 plasma levels. Identification of new molecular biomarkers based on pharmacogenomic exploratory analyses. | — |
Countries
Germany, United Kingdom
Contacts
Public ContactMatthias Schwab
Dr. Margarete Fischer Bosch Institut für Klinische Pharmakologie
Outcome results
None listed