Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling.
研究概览
简要总结
This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.
详细描述
Therapeutic drug monitoring (TDM) could serve as a valuable tool to minimize adverse events and maximize the efficacy of treatment in breast cancer patients receiving CDK4/6 inhibitors (ribociclib, abemaciclib, palbociclib). However, current TDM performed via venous blood draws can be inconvenient, especially for repeated sampling.
This study aims to evaluate the reliability of capillary (fingertip) microsampling-which could be performed at home as a less invasive alternative to standard venous sampling for measuring residual drug concentrations.
Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen): 4 capillary samples (using the VAMS Mitra device) including 2 samples collected by the study nurse who will train the patient to perform the 2 following samples him/herself; and 1 venous sample (5 mL heparinized tube).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years) with breast cancer.
- •Patients currently receiving ribociclib, abemaciclib, or palbociclib.
- •Patients capable of performing capillary sampling (with or without assistance).
- •Patient information and signing of informed consent.
- •Patient ability to comply with protocol requirements.
- •Patients covered by a health insurance system.
排除标准
- •Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
- •Persons deprived of their liberty or under guardianship.
研究组 & 干预措施
Blood samples collection in breast cancer in patients receiving CDK4/6 inhibitors
Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen).
The patients will also complete an acceptability Questionnaire following the samplings.
干预措施: Capillary samples using the VAMS Mitra device (Other)
结局指标
主要结局
Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling.
时间窗: Day 1
The primary objective of the study is therefore to validate the reliability of capillary sampling (using the VAMS Mitra device) as an alternative to venous sampling for TDM of CDK4/6 inhibitors (ribociclib, abemaciclib, or palbociclib) in breast cancer patients. The primary endpoint will be the concordance between drug concentrations obtained from venous and capillary samples, assessed through Bland-Altman analysis.
次要结局
- Intra-patient's variability of the measurements from microsamplings(Day 1)
- Acceptability of the device, as assessed by a patient satisfaction questionnaire.(Day 1)