RecruitingPhase 4NCT07252726

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)


Sponsor

Ottawa Hospital Research Institute

Enrollment

50 participants

Start Date

Feb 2, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study asks a simple but important question: does it matter whether cancer patients take their hormone-based medications in the morning versus the evening? It focuses on patients with metastatic breast cancer or metastatic prostate cancer who are starting hormone therapy combined with a cancer growth inhibitor, and will track symptoms and quality of life in both groups. **You may be eligible if...** - Breast cancer: You have metastatic hormone receptor-positive breast cancer and are starting a CDK4/6 inhibitor (ribociclib or palbociclib) plus endocrine therapy for the first time in the metastatic setting - Prostate cancer: You have metastatic castrate-sensitive prostate cancer and are starting an androgen receptor pathway inhibitor (enzalutamide, apalutamide, or abiraterone) combined with androgen deprivation therapy - You are 18 or older and able to complete questionnaires **You may NOT be eligible if...** - You have any medical reason that prevents taking your medication at a specific time of day - Breast cancer: You are taking abemaciclib (requires twice-daily dosing) - Prostate cancer: You are taking darolutamide or planning to add docetaxel chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMorning 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.

OTHEREvening administration of CDK4/6 inhibitor

Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.

OTHERMorning administration of ARPI

Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.

OTHEREvening 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

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NCT07252726


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