Therapeutic Dose Monitoring (TDM) of Tamoxifen and Its Active Metabolites in Combination With Patient-reported Symptom Scores Among Patients With Breast Cancer Receiving Adjuvant Tamoxifen Treatment
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To validate the rhelise™ kit for monitoring tamoxifen, 4-hydroxytamoxifen and Z-endoxifen among patients recommended or who have ongoing adjuvant tamoxifen.
Study Overview
Brief 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.
Detailed Description
This repeated-measures, prospective, open-label, single-centre study is designed for women with stage 0-3 breast cancer receiving adjuvant tamoxifen 20 mg/day.
Inclusion criteria:
- Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
- Ongoing daily adjuvant tamoxifen minimum of 2 months ± gonadotropin-releasing hormone (GnRH) analogues ± radiation therapy (RT) for stage 3 breast cancer.
- Locally recurrent disease, previously treated with adjuvant tamoxifen.
- Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
- Have small, wireless computing devices, such as smartphones and tablets.
Exclusion Criteria:
- Fulfilling any of the contraindications for tamoxifen.
- Metastatic (stage IV) breast cancer.
- Included in other clinical studies receiving not approved investigational medicinal drug.
- Ongoing pregnancy or lactation.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged ≥ 18 years with hormone-positive stage 0-3 breast cancer.
- •Performance status ECOG 0-
- •Ongoing daily adjuvant tamoxifen minimum of 2 months ± GnRH analogues ± RT for stage 3 breast cancer.
- •Locally recurrent disease, previously treated with adjuvant tamoxifen.
- •Able to use software applications developed specifically for small, wireless computing devices, such as smartphones and tablets.
- •Have small, wireless computing devices, such as smartphones and tablets.
Exclusion Criteria
- •Fulfilling any of the contraindications for tamoxifen.
- •Metastatic (stage IV) breast cancer.
- •Included in other clinical studies receiving not approved investigational medicinal drug.
- •Ongoing pregnancy or lactation.
- •Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Arms & Interventions
0
Blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen will be measured.
Intervention: Tamoxifen 20 mg (Drug)
Outcomes
Primary Outcomes
To validate the rhelise™ kit for monitoring tamoxifen, 4-hydroxytamoxifen and Z-endoxifen among patients recommended or who have ongoing adjuvant tamoxifen.
Time Frame: At week 3 after inclusion for each participant.
Blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen at baseline, two weeks, 1, 2, and 3 weeks by capillary and venous blood sampling (whole blood/plasma).
Secondary Outcomes
- To test the correlations of concentrations found in the capillary sample (rhelise™ kit) and the venous blood sample (gold standard).(At 4-time points, at inclusion (baseline), and after 1, 2, and 3 weeks for each participant.)
- Symptom distresses scores measured by the patient interactive digital tool (application) mBraze.(at baseline and 3 weeks.)
- To compare and correlate blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen with patient-reported outcome measures and the application mBraze for symptom self-monitoring.(at baseline and 3 weeks)
- To validate the user experience of the mBraze app.(at 3 weeks.)
- To validate user acceptability and feasibility of self-testing the capillary kit.(At 4-time points, at inclusion (baseline), and after 1, 2, and 3 weeks for each participant.)
- To validate the usability of the mBraze app.(at 3 weeks.)
- To determine user acceptability and attitudes toward self-testing.(at 3 weeks.)
Investigators
Elham Hedayati
MD, PhD
Karolinska University Hospital