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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To validate the rhelise™ kit for monitoring tamoxifen, 4-hydroxytamoxifen and Z-endoxifen among patients recommended or who have ongoing adjuvant tamoxifen.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
0
Blood concentrations of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen will be measured.
干预措施: Tamoxifen 20 mg (Drug)
结局指标
主要结局
To validate the rhelise™ kit for monitoring tamoxifen, 4-hydroxytamoxifen and Z-endoxifen among patients recommended or who have ongoing adjuvant tamoxifen.
时间窗: 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).
次要结局
- 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.)
研究者
Elham Hedayati
MD, PhD
Karolinska University Hospital