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

NCT07252726 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Hospital Research Institute

Phase

Phase 4

Started

2026-02-02

Last updated

2026-07-17

Condition(s) studied

Metastatic Breast CancerMetastatic Prostate Cancer

Investigational drug(s) / intervention(s)

Morning administration of CDK4/6 inhibitorEvening administration of CDK4/6 inhibitorMorning administration of ARPIEvening administration of ARPI

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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) Exclusion Criteria * 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

Primary outcome measure(s)

Feasibility: accrual per site — 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 — 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 — 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.

Trial sites (3)

Facility	City	Region	Status
Waterloo Regional Health Network	Kitchener	Ontario	Recruiting
The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Recruiting
Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07252726 on ClinicalTrials.gov ↗ ← All trials in Canada