Morning versus evening timing of hormone therapy for metastatic breast and prostate cancer
Official title: 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)
Run by Ottawa Hospital Research Institute · NCT07252726 · Data updated 2026-11-12
This pilot will test whether taking hormone-based cancer drugs in the morning or in the evening works better for people with metastatic breast or prostate cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 3 sites (Kitchener, Ontario and 2 other locations) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2033 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT07252726 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with metastatic HR+ breast cancer planned for first-line CDK4/6 plus endocrine therapy, or adults with metastatic castrate-sensitive prostate cancer planned for an ARPI plus ADT, who can provide consent and complete study questionnaires are ideal candidates.
✕Probably not a fit
Patients on twice-daily regimens (such as abemaciclib), those with contraindications to morning or evening dosing, or those not starting the specified endocrine regimens are unlikely to benefit from this timing comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with metastatic hormone receptor–positive breast cancer starting a CDK4/6 inhibitor plus endocrine therapy, and patients with metastatic castrate-sensitive prostate cancer starting an androgen receptor pathway inhibitor plus ADT, will be randomized to take their oral endocrine therapy in the morning or in the evening. The primary focus of this pilot is feasibility to determine if a larger definitive trial can be conducted, while secondary measures compare quality of life, tolerability, and preliminary efficacy within each cohort. The breast cohort will use ribociclib or palbociclib (abemaciclib is excluded because it is dosed twice daily), and the prostate cohort will include enzalutamide, apalutamide, or abiraterone. The phase 4 pilot will be conducted across multiple Canadian cancer centers to inform a future larger trial.
Why it matters
Potential benefit: If successful, timing therapy could reduce side effects or improve control of metastatic disease, making treatment easier to tolerate and potentially more effective.
How similar studies have gone: Chronotherapy has produced mixed results in other cancers and conditions, and timing of oral endocrine agents in metastatic breast or prostate cancer is relatively untested and therefore novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Waterloo Regional Health Network
Kitchener, Ontario, Canada Recruiting -
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada Recruiting -
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada Not yet recruiting
Study contacts
- Principal investigator: Marie-France Savard, MD — The Ottawa Hospital
- Study coordinator: Lisa Vandermeer, MSc
- Email: lvandermeer@ohri.ca
- Phone: 613-737-7700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.