NCT07252726 Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
| NCT ID | NCT07252726 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2026-02-02 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Marie-France Savard, MD
PRINCIPAL INVESTIGATOR
The Ottawa Hospital
Frequently Asked Questions
Who can join the NCT07252726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07252726 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07252726 currently recruiting?
Yes, NCT07252726 is actively recruiting participants. Contact the research team at lvandermeer@ohri.ca for enrollment information.
Where is the NCT07252726 trial being conducted?
This trial is being conducted at Kitchener, Canada, Ottawa, Canada, Saskatoon, Canada.
Who is sponsoring the NCT07252726 clinical trial?
NCT07252726 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Marie-France Savard, MD at The Ottawa Hospital. The trial plans to enroll 50 participants.
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