Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
NCT ID: NCT07252726
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2026-01-31
2033-02-28
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A, Arm A: Breast Cancer Cohort, Morning Group
Participants with metastatic breast cancer in this arm are assigned morning administration of CDK4/6 inhibitor.
Morning administration of CDK4/6 inhibitor
Morning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time.
Cohort A, Arm B: Breast Cancer Cohort, Evening Group
Participants with metastatic breast cancer in this arm are assigned evening administration of CDK4/6 inhibitor.
Evening administration of CDK4/6 inhibitor
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
Cohort B, Arm A: Prostate Cancer Cohort, Morning Group
Participants with metastatic prostate cancer in this arm are assigned morning administration of ARPI.
Morning administration of ARPI
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Cohort B, Arm B: Prostate Cancer Cohort, Evening Group
Participants with metastatic prostate cancer in this arm are assigned evening administration of ARPI.
Evening administration of ARPI
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Interventions
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Morning administration of CDK4/6 inhibitor
Morning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time.
Evening administration of CDK4/6 inhibitor
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
Morning administration of ARPI
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Evening administration of ARPI
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Plan to receive abemaciclib (as this requires twice a day dosing)
* 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
18 Years
ALL
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Marie-France Savard, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Ana-Alicia Beltran-Bless, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Lauren Butterfield, MSc
Role: primary
References
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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.
Savard 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.
Related Links
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The Rethinking Clinical Trials (REaCT) website
Other Identifiers
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REaCT-CHRONO-MetBP Pilot
Identifier Type: -
Identifier Source: org_study_id
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