Actively Recruiting
Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
Led by Ottawa Hospital Research Institute · Updated on 2026-02-09
50
Participants Needed
3
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For breast cancer cohort: metastatic hormone receptor-positive breast cancer
- Plan to receive endocrine therapy and a CDK4/6 inhibitor (Ribociclib or Palbociclib) as first-line metastatic treatment
- Able to provide oral consent
- Willing and able to complete questionnaires
- For prostate cancer cohort: metastatic castrate-sensitive prostate cancer
- Plan to receive androgen receptor pathway inhibitor (enzalutamide, apalutamide, or abiraterone acetate) with androgen deprivation therapy
- Able to provide oral consent
- Willing and able to complete questionnaires
You will not qualify if you...
- Contraindication to taking endocrine therapy and CDK4/6 inhibitor in the morning or evening (breast cohort)
- Plan to receive abemaciclib (due to twice daily dosing)
- Contraindication to taking androgen receptor pathway inhibitor in the morning or evening (prostate cohort)
- Plan to receive darolutamide (due to twice daily dosing)
- Plan to receive docetaxel combined with androgen receptor pathway inhibitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Waterloo Regional Health Network
Kitchener, Ontario, Canada
Not Yet Recruiting
2
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
3
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Not Yet Recruiting
Research Team
L
Lisa Vandermeer, MSc
CONTACT
L
Lauren Butterfield, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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