Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
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)
Ottawa Hospital Research Institute
50 participants
Feb 2, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria10
- 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
- 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
Exclusion Criteria5
- 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)
- 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
Interventions
Morning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time.
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Locations(3)
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NCT07252726