Trial Information
A Multi-Centre Study of Tamoxifen Dose Escalation Study in Breast Cancer Patients With CYP2D6 Polymorphisms
Inclusion Criteria:
- ECOG performance status ≤ 1
- Life expectancy ≥ 6 months
- Histologically or cytologically confirmed early, locally advanced or metastatic
breast cancer
- Oestrogen receptor positive
- About to start tamoxifen treatment or already on tamoxifen 20mg daily
- Adequate hepatic and renal function
Exclusion Criteria:
- Concurrent chemotherapy or radiotherapy
- Treatment with medications that may alter cytochrome P450 (CYP450)3A4/5 and CYP2D6
activities
- History of thrombosis
- History of non-compliance with previous or current treatment;
- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Effects of genotype of CYP2D on plasma and serum concentration of tamoxifen and its metabolites, with consequent recommendation for dosage adjustment
Outcome Time Frame:
dose escalation over 40 weeks
Safety Issue:
No
Principal Investigator
Howard Gurney, MBBS,FRACP
Investigator Role:
Principal Investigator
Investigator Affiliation:
South West Sydney Local Health District
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
TADE study
NCT ID:
NCT01075802
Start Date:
March 2010
Completion Date:
December 2012
Related Keywords:
- Breast Cancer
- CYP2D6 Polymorphism
- Breast cancer
- Tamoxifen
- Endoxifen
- polymorphism of CYP2D6
- Breast Neoplasms