Comparing 4 approaches for metastatic breast cancer
Official title: 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)
Interventions
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.
Canadian Sites (3)
Waterloo Regional Health Network
Kitchener, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years
- +Age ≥18 years
- +Patients with metastatic hormonal receptor positive breast cancer
- +Patients with metastatic castrate sensitive prostate cancer
- +Plan to receive endocrine therapy and a CDK4/6 inhibitor (either Ribociclib or Palbociclib) in the first-line metastatic setting
- +Able to provide oral consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Willing and able to complete questionnaires as per study protocolProtocolThe detailed plan a study must follow.Read more →
- +CohortCohortA group of participants sharing a characteristic, followed together.Read more → A (Breast Cohort) Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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 CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →
- +Plan to receive androgen receptor pathway inhibitor (either enzalutamide, apalutamide or abiraterone acetate) in combination with androgen deprivation therapy
- +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
Exclusion
- −Age ≥18 years
- −Patients with metastatic castrate sensitive prostate cancer
- −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)
- −CohortCohortA group of participants sharing a characteristic, followed together.Read more → B (Prostate Cancer) Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →
- −Plan to receive androgen receptor pathway inhibitor (either enzalutamide, apalutamide or abiraterone acetate) in combination with androgen deprivation therapy
- −Able to provide oral consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Willing and able to complete questionnaires as per study protocolProtocolThe detailed plan a study must follow.Read more →
- −Cohort B (Prostate Cancer) Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
What is being given or done in this study: Morning administration of CDK4/6 inhibitor, Evening administration of CDK4/6 inhibitor, Morning administration of ARPI, Evening administration of ARPI.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around March 2033.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility: accrualEnrolmentThe number of participants a study plans to include, or has included.Read more → per siteTrial siteA hospital or clinic where a study is actually run.Read more → — measured over 1 year.
Feasibility: participation rate — measured over The accrual period, approximately 1 year.
Feasibility: number of participants who received allocated intervention — measured over 4 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07252726 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Morning administration of CDK4/6 inhibitorOther
Morning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Evening administration of CDK4/6 inhibitorOther
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Morning administration of ARPIOther
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Evening administration of ARPIOther
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2033-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Kitchener, Ontario, Canada; Ottawa, Ontario, Canada; Saskatoon, Saskatchewan, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.