Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
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
Trial design
Design model
Parallel
Treatments tested in this trial
Morning administration of CDK4/6 inhibitor
Other interventionMorning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time.
Evening administration of CDK4/6 inhibitor
Other interventionEvening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
Morning administration of ARPI
Other interventionMorning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Evening administration of ARPI
Other interventionEvening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: Cohort A, Arm A: Breast Cancer Cohort, Morning GroupActive comparator 1 intervention
Group B: Cohort A, Arm B: Breast Cancer Cohort, Evening GroupActive comparator 1 intervention
Group C: Cohort B, Arm A: Prostate Cancer Cohort, Morning GroupActive comparator 1 intervention
Group D: Cohort B, Arm B: Prostate Cancer Cohort, Evening GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: accrual per site
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
Time frame
1 year2
Feasibility: participation rate
Feasibility will be assessed according to a combination of metrics, including participation rate of at least 60% among patients approached.
Time frame
The accrual period, approximately 1 year3
Feasibility: number of participants who received allocated intervention
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.
Time frame
4 weeksSecondary outcomes
1
Health-related quality of life: Functional Assessment of Cancer Therapy-General
Health-related quality of life using Functional Assessment of Cancer Therapy-General (FACT-G). Cohort A and Cohort B will answer the FACT-G. FACT-G has a score range of 0 to 108. Higher scores indicate better quality of life.
Time frame
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years2
Health-related quality of life: Functional Assessment of Cancer Therapy-Endocrine Symptoms
Health-related quality of life using Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES). Cohort A and Cohort B will answer the FACT-ES. FACT-ES has a score range of 0 to 184. Higher scores indicate better quality of life.
Time frame
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years3
Health-related quality of life: Functional Assessment of Cancer Therapy-Breast
Health-related quality of life using Functional Assessment of Cancer Therapy-Breast (FACT-B). Cohort A will complete the FACT-B. FACT-B has a score range of 0 to 148. Higher scores indicate better quality of life.
Time frame
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years4
Health-related quality of life: Functional Assessment of Cancer Therapy-Prostate
Health-related quality of life using Functional Assessment of Cancer Therapy-Prostate (FACT-P). Cohort B will complete the FACT-P. FACT-P has a score range of 0 to 156. Higher scores indicate better quality of life.
Time frame
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-yearsOther outcomes
1
Time to second-line systemic treatment
Time from the randomization to start of second-line systematic treatment. This is reported on the Health Care Provider (HCP) follow up questionnaire which is completed at the various timepoints outlined in the time frame.
Time frame
4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years2
Overall survival
Overall survival is the time from randomization to death from any cause. Survival status (yes/no) will be checked throughout the study at the various timepoints outlined in the time frame.
Time frame
4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years, 6-years post-randomization.3
PSA reduction at 6 months
Cohort B only: prostate-specific antigen reduction.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov