NCT07252726RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 2 Feb 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Prostate cancer, Metastatic breast cancer
- NCT number
- NCT07252726
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 2 Feb 2026 to the primary completion date, Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Waterloo Regional Health Network Coordinator of this site? Confirm its status | Kitchener | Canada | Recruiting |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Saskatoon Cancer Centre Coordinator of this site? Confirm its status | Saskatoon | Canada | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.