Clareo Health | Dose-determining and Dose-confirmatory Study to Investigate the Optimal Dose of Tamoxifen in Breast Cancer Patients According to Genotype Status of TCF20 rs932376
Dose-determining and Dose-confirmatory Study to Investigate the Optimal Dose of Tamoxifen in Breast Cancer Patients According to Genotype Status of TCF20 rs932376
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Cancer Centre, Singapore
With
National Medical Research Council (NMRC), Singapore
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed stage I to IV breast cancer
Age greater than 21 years
Estrogen- or progesterone-receptor positive tumours
Patients receiving tamoxifen 20mg daily as monotherapy
Patients currently taking tamoxifen in either adjuvant or metastatic setting for greater than or equal to 8 weeks (for Dose determination and confirmation phases)
Patients who will commence on tamoxifen therapy in either adjuvant or metastatic setting (for Dose confirmation phase only)
Written and informed consent from participating patients
You may not be if
Patients with expected survival less than 6 months
Patients who are human epidermal growth factor receptor 2 (HER2)-postitive
Inability to provide informed consent
Patients receiving CYP2D6 inhibitors or inducers within the past four weeks from the time of study enrollment. However, patients started in CYP2D6 inhibitors or inducers after commencing on tamoxifen therapy will not be excluded from the study.
Pregnancy
Patients with prior malignancies other than those who have received curative treatment for basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements.
Patients who have documented prior allergic reaction to tamoxifen
