NCT07252726

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Breast Cancer
• Metastatic Prostate Cancer

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	Morning administration of ARPI	Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
OTHER	Evening administration of ARPI	Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-03-01
• Completion: 2033-03-01
• First posted: 2025-11-28
• Last updated: 2026-02-09

Locations

3 sites across 1 country: Canada