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)
1 other identifier
interventional
50
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2026
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2033
February 9, 2026
February 1, 2026
1.1 years
September 18, 2025
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility: accrual per site
Feasibility will be assessed according to a combination of metrics, including the accrual of at least 25 patients per cohort in one year for a total of three sites
1 year
Feasibility: participation rate
Feasibility will be assessed according to a combination of metrics, including participation rate of at least 60% among patients approached.
The accrual period, approximately 1 year
Feasibility: number of participants who received allocated intervention
Feasibility will be assessed according to a combination of metrics, including at least 80% of enrolled patients receive treatment as per their allocated intervention for at least 4 weeks.
4 weeks
Secondary Outcomes (11)
Health-related quality of life: Functional Assessment of Cancer Therapy-General
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Health-related quality of life: Functional Assessment of Cancer Therapy-Endocrine Symptoms
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Health-related quality of life: Functional Assessment of Cancer Therapy-Breast
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Health-related quality of life: Functional Assessment of Cancer Therapy-Prostate
Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Number of changes in treatment dose
5 years
- +6 more secondary outcomes
Other Outcomes (3)
Time to second-line systemic treatment
4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Overall survival
4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years, 6-years post-randomization.
PSA reduction at 6 months
6 months
Study Arms (4)
Cohort A, Arm A: Breast Cancer Cohort, Morning Group
ACTIVE COMPARATORParticipants with metastatic breast cancer in this arm are assigned morning administration of CDK4/6 inhibitor.
Cohort A, Arm B: Breast Cancer Cohort, Evening Group
ACTIVE COMPARATORParticipants with metastatic breast cancer in this arm are assigned evening administration of CDK4/6 inhibitor.
Cohort B, Arm A: Prostate Cancer Cohort, Morning Group
ACTIVE COMPARATORParticipants with metastatic prostate cancer in this arm are assigned morning administration of ARPI.
Cohort B, Arm B: Prostate Cancer Cohort, Evening Group
ACTIVE COMPARATORParticipants with metastatic prostate cancer in this arm are assigned evening administration of ARPI.
Interventions
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Morning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Waterloo Regional Health Network
Kitchener, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Related Publications (2)
Beltran-Bless AA, Vandermeer L, Ibrahim MFK, Hutton B, Shorr R, Savard MF, Clemons M. Does the Time of Day at Which Endocrine Therapy Is Taken Affect Breast Cancer Patient Outcomes? Curr Oncol. 2021 Jul 6;28(4):2523-2528. doi: 10.3390/curroncol28040229.
PMID: 34287262BACKGROUNDSavard MF, Ibrahim M, Saunders D, Pond GR, Ng TL, Awan AA, Sehdev S, Alqahtani N, Vandermeer L, MacDonald F, Beltran-Bless AA, Fallowfield L, Clemons M. A pragmatic, multicenter, randomized trial comparing morning versus evening dosing of adjuvant endocrine therapy (REaCT-CHRONO Study). NPJ Breast Cancer. 2025 May 29;11(1):49. doi: 10.1038/s41523-025-00762-7.
PMID: 40442096BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-France Savard, MD
The Ottawa Hospital
- PRINCIPAL INVESTIGATOR
Ana-Alicia Beltran-Bless, MD
The Ottawa Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants and investigators will not be blinded to treatment allocation as the study is only randomizing treatment schedule.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2025
First Posted
November 28, 2025
Study Start
February 2, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2033
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share