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Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
Sponsor: Ottawa Hospital Research Institute
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-02-02
Completion Date
2033-03
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
Morning administration of CDK4/6 inhibitor
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
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
Morning administration of ARPI
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Evening administration of ARPI
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Locations (3)
Waterloo Regional Health Network
Kitchener, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada