Overview

Therapeutic Dose Monitoring (TDM) of Tamoxifen

Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Tamoxifen is a potent and effective drug reducing the risk of dying from breast cancer in the adjuvant setting. Although more modern drugs have partly replaced tamoxifen, it is helpful in the neoadjuvant and metastatic settings as a single drug. Despite that, in the adjuvant setting, it is a valuable drug. This study aims to validate and study the feasibility of serial assessments, including therapeutic drug monitoring of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen by capillary blood sampling, combined with patient-reported symptom scores. This will provide preliminary data to allow us to develop a future multicentre randomised clinical trial of personalised dose monitoring and adjustment of adjuvant tamoxifen therapy to enhance the quality of life and breast cancer outcomes.
Phase:
Phase 2
Details
Lead Sponsor:
Karolinska University Hospital
Treatments:
Tamoxifen