Metastatic Breast CancerPhase 4NCT07252726
Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
A Phase 4 study testing Morning administration of CDK4/6 inhibitor, Evening administration of CDK4/6 inhibitor and Morning administration of ARPI in people with Metastatic Breast Cancer and Metastatic Prostate Cancer, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Prostate Cancer
- What is being tested?
- Morning administration of CDK4/6 inhibitor, Evening administration of CDK4/6 inhibitor and Morning administration of ARPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- 2 Feb 2026to Mar 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Waterloo Regional Health Network
Kitchener, Ontario
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Lauren Butterfield, MSc, 613-737-7700, lbutterfield@ohri.ca
- Not yet recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan
About this study
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)
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).
- Being tested
- Morning administration of CDK4/6 inhibitor, Evening administration of CDK4/6 inhibitor, Morning administration of ARPI, Evening administration of ARPI
- Keywords
- Chronotherapy, breast cancer, prostate cancer, endocrine therapy, metastatic cancer
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Morning administration of ARPIOther
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
Evening administration of ARPIOther
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A, Arm A: Breast Cancer Cohort, Morning Group | Active comparator | Participants with metastatic breast cancer in this arm are assigned morning administration of CDK4/6 inhibitor. Receives: Other: Morning administration of CDK4/6 inhibitor |
| Cohort A, Arm B: Breast Cancer Cohort, Evening Group | Active comparator | Participants with metastatic breast cancer in this arm are assigned evening administration of CDK4/6 inhibitor. Receives: Other: Evening administration of CDK4/6 inhibitor |
| Cohort B, Arm A: Prostate Cancer Cohort, Morning Group | Active comparator | Participants with metastatic prostate cancer in this arm are assigned morning administration of ARPI. Receives: Other: Morning administration of ARPI |
| Cohort B, Arm B: Prostate Cancer Cohort, Evening Group | Active comparator | Participants with metastatic prostate cancer in this arm are assigned evening administration of ARPI. Receives: Other: Evening administration of ARPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (11)
Health-related quality of life: Functional Assessment of Cancer Therapy-General
Health-related quality of life using Functional Assessment of Cancer Therapy-General (FACT-G). Cohort A and Cohort B will answer the FACT-G. FACT-G has a score range of 0 to 108. Higher scores indicate better quality of life.
Measured: 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
Health-related quality of life using Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES). Cohort A and Cohort B will answer the FACT-ES. FACT-ES has a score range of 0 to 184. Higher scores indicate better quality of life.
Measured: 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
Health-related quality of life using Functional Assessment of Cancer Therapy-Breast (FACT-B).
Cohort A will complete the FACT-B. FACT-B has a score range of 0 to 148. Higher scores indicate better quality of life.
Measured: 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
Health-related quality of life using Functional Assessment of Cancer Therapy-Prostate (FACT-P).
Cohort B will complete the FACT-P. FACT-P has a score range of 0 to 156. Higher scores indicate better quality of life.
Measured: Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Number of changes in treatment dose
Measured: 5 years
Number of treatment interruptions
Measured: 5 years
Number of treatment discontinuations
Measured: 5 years
Cohort A's adverse events of interest
The number of participants in Cohort A that experience QTc prolongation, neutropenia, febrile neutropenia, hepatobiliary function.
Measured: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Cohort B's adverse events of interest
The number of participants in Cohort B that experience hypertension, hyperglycemia, rash, hypothyroidism, fatigue.
Measured: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Adherence to treatment
Adherence to treatment measured by the Five-Item Medication Adherence Report Scale (MARS-5 score). The MARS-5 has a range of 5-25. Higher scores indicate high adherence.
Measured: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Participant preference in dose timing
Participants rank their preference on a scale of 0 to 10, where 0=prefer to take treatment in the morning, 5=no preference, 10=prefer to take treatment in the evening.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start2 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 2 cohorts. Cohort A is for participants with breast cancer. Participants in Cohort A will be randomized to either morning or evening administration of endocrine-based therapy for breast cancer. Cohort B is for participants with prostate cancer. Participants in Cohort B will be randomized to either morning or evening administration of endocrine-based therapy for prostate cancer.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-France Savard, MD, Principal investigator, The Ottawa HospitalAna-Alicia Beltran-Bless, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252726
- Sponsor's protocol ID
- REaCT-CHRONO-MetBP Pilot
- Status last verified
- Jul 2026
- First submitted
- 18 Sep 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34287262Savard 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.
PubMed 40442096
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07252726
- Acronym / sponsor ID
- REaCT-CHRONO-MetBP Pilot
- Keywords
- Chronotherapy, breast cancer, prostate cancer, endocrine therapy, metastatic cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There will be 2 cohorts. Cohort A is for participants with breast cancer. Participants in Cohort A will be randomized to either morning or evening administration of endocrine-based therapy for breast cancer. Cohort B is for participants with prostate cancer. Participants in Cohort B will be randomized to either morning or evening administration of endocrine-based therapy for prostate cancer.
| Arm | Type | Receives |
|---|---|---|
| Cohort A, Arm A: Breast Cancer Cohort, Morning Group | Active comparator | Other: Morning administration of CDK4/6 inhibitorParticipants 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 comparator | Other: Evening administration of CDK4/6 inhibitorParticipants 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 comparator | Other: Morning administration of ARPIParticipants with metastatic prostate cancer in this arm are assigned morning administration of ARPI. |
| Cohort B, Arm B: Prostate Cancer Cohort, Evening Group | Active comparator | Other: Evening administration of ARPIParticipants with metastatic prostate cancer in this arm are assigned evening administration of ARPI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning administration of CDK4/6 inhibitorMorning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time. | Other | Cohort A, Arm A: Breast Cancer Cohort, Morning Group |
| Evening administration of CDK4/6 inhibitorEvening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime. | Other | Cohort A, Arm B: Breast Cancer Cohort, Evening Group |
| Morning administration of ARPIMorning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time. | Other | Cohort B, Arm A: Prostate Cancer Cohort, Morning Group |
| Evening administration of ARPIEvening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime. | Other | Cohort B, Arm B: Prostate Cancer Cohort, Evening Group |
Primary outcome
Feasibility: accrual per site
Time frame: 1 year
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
Feasibility: participation rate
Time frame: The accrual period, approximately 1 year
Feasibility will be assessed according to a combination of metrics, including participation rate of at least 60% among patients approached.
Feasibility: number of participants who received allocated intervention
Time frame: 4 weeks
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.
11 secondary outcomes
Health-related quality of life: Functional Assessment of Cancer Therapy-General
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Number of changes in treatment dose
Time frame: 5 years
Number of treatment interruptions
Time frame: 5 years
Number of treatment discontinuations
Time frame: 5 years
Cohort A's adverse events of interest
Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Cohort B's adverse events of interest
Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Adherence to treatment
Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years
Participant preference in dose timing
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 34287262Beltran-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.
- Background: PubMed 40442096Savard 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.
- The Rethinking Clinical Trials (REaCT) websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-France Savard, MD principal investigator
The Ottawa Hospital
Ana-Alicia Beltran-Bless, MD principal investigator
The Ottawa Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morning administration of CDK4/6 inhibitor, Evening administration of CDK4/6 inhibitor and Morning administration of ARPI in people with Metastatic Breast Cancer and Metastatic Prostate Cancer, run by Ottawa Hospital Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Vandermeer, MSc (613-737-7700, lvandermeer@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: accrual per site (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07252726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.