Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT07252726
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Morning administration of CDK4/6 inhibitor — OTHER
    Morning 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
    Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
  • Morning administration of ARPI — OTHER
    Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
  • Evening administration of ARPI — OTHER
    Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.

Study Details

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).

Key Dates

First listed
Nov 28, 2025
Start date
Feb 2, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2033

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: Cohort B, Arm A: Prostate Cancer Cohort, Morning Group
    Participants with metastatic prostate cancer in this arm are assigned morning administration of ARPI.
  • Active Comparator: Cohort B, Arm B: Prostate Cancer Cohort, Evening Group
    Participants with metastatic prostate cancer in this arm are assigned evening administration of ARPI.

Primary Outcome Measure

Feasibility: accrual per site [ Time Frame: 1 year ]

Central Contacts

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