A Randomised, Multicentre Trial Evaluating the Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers (REaCT-CHRONO-MetBP Pilot Study)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Feasibility: accrual per site
研究概览
简要总结
The REaCT-CHRONO-MetBP Pilot study will compare morning and evening administration of endocrine-based therapy in metastatic breast and prostate cancers.
Participants with metastatic breast or prostate cancer will be randomly placed in one of two groups: a morning group and an evening group. The group assignment will determine whether they take their endocrine therapy in the morning or the evening. The primary outcome of this pilot study is to evaluate the feasibility of study procedures in order to conduct a larger definitive trial in the future. The secondary outcomes include comparing quality of life, tolerability, and efficacy outcomes between the morning and evening groups for each of the two cancer cohorts (metastatic breast and prostate cancer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants and investigators will not be blinded to treatment allocation as the study is only randomizing treatment schedule.
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
- •Cohort A (Breast Cohort) Inclusion Criteria
- •Patients with metastatic hormonal receptor positive breast cancer
- •Plan to receive endocrine therapy and a CDK4/6 inhibitor (either Ribociclib or Palbociclib) in the first-line metastatic setting
- •Age ≥18 years
- •Able to provide oral consent
- •Willing and able to complete questionnaires as per study protocol
- •Cohort A (Breast Cohort)
排除标准
- •Any contraindication in taking endocrine therapy and CDK4/6 inhibitor in the morning or evening
- •Plan to receive abemaciclib (as this requires twice a day dosing)
- •Cohort B (Prostate Cancer) Inclusion Criteria
- •Patients with metastatic castrate sensitive prostate cancer
- •Plan to receive androgen receptor pathway inhibitor (either enzalutamide, apalutamide or abiraterone acetate) in combination with androgen deprivation therapy
- •Age ≥18 years
- •Able to provide oral consent
- •Willing and able to complete questionnaires as per study protocol
- •Cohort B (Prostate Cancer) Exclusion Criteria
- •Any contraindication in taking androgen receptor pathway inhibitor in the morning or evening
- •Plan to receive darolutamide (as this requires twice a day dosing)
- •Plan to receive docetaxel in combination with androgen receptor pathway inhibitor
研究组 & 干预措施
Cohort A, Arm A: Breast Cancer Cohort, Morning Group
Participants with metastatic breast cancer in this arm are assigned morning administration of CDK4/6 inhibitor.
干预措施: Morning administration of CDK4/6 inhibitor (Other)
Cohort A, Arm B: Breast Cancer Cohort, Evening Group
Participants with metastatic breast cancer in this arm are assigned evening administration of CDK4/6 inhibitor.
干预措施: Evening administration of CDK4/6 inhibitor (Other)
Cohort B, Arm A: Prostate Cancer Cohort, Morning Group
Participants with metastatic prostate cancer in this arm are assigned morning administration of ARPI.
干预措施: Morning administration of ARPI (Other)
Cohort B, Arm B: Prostate Cancer Cohort, Evening Group
Participants with metastatic prostate cancer in this arm are assigned evening administration of ARPI.
干预措施: Evening administration of ARPI (Other)
结局指标
主要结局
Feasibility: accrual per site
时间窗: 1 year
Feasibility will be assessed according to a combination of metrics, including the accrual of at least 25 patients per cohort in one year for a total of three sites
Feasibility: participation rate
时间窗: The accrual period, approximately 1 year
Feasibility will be assessed according to a combination of metrics, including participation rate of at least 60% among patients approached.
Feasibility: number of participants who received allocated intervention
时间窗: 4 weeks
Feasibility will be assessed according to a combination of metrics, including at least 80% of enrolled patients receive treatment as per their allocated intervention for at least 4 weeks.
次要结局
- Participant preference in dose timing(Baseline)
- Adherence to treatment(4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years)
- Health-related quality of life: Functional Assessment of Cancer Therapy-General(Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years)
- Health-related quality of life: Functional Assessment of Cancer Therapy-Endocrine Symptoms(Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years)
- Health-related quality of life: Functional Assessment of Cancer Therapy-Breast(Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years)
- Health-related quality of life: Functional Assessment of Cancer Therapy-Prostate(Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years)
- Number of changes in treatment dose(5 years)
- Number of treatment interruptions(5 years)
- Number of treatment discontinuations(5 years)
- Cohort A's adverse events of interest(4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years)
- Cohort B's adverse events of interest(4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years)