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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morning administration of CDK4/6 inhibitor | Other | Morning administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant wake up time. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to second-line systemic treatment | Time from the randomization to start of second-line systematic treatment. This is reported on the Health Care Provider (HCP) follow up questionnaire which is completed at the various timepoints outlined in the time frame. | 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years |
Cohort A (Breast Cohort) Inclusion Criteria
Cohort A (Breast Cohort) Exclusion Criteria
Cohort B (Prostate Cancer) Inclusion Criteria
Cohort B (Prostate Cancer) Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Vandermeer, MSc | Contact | 613-737-7700 | lvandermeer@ohri.ca | |
| Lauren Butterfield, MSc | Contact | 613-737-7700 | lbutterfield@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Marie-France Savard, MD | The Ottawa Hospital | Principal Investigator |
| Ana-Alicia Beltran-Bless, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waterloo Regional Health Network | Recruiting | Kitchener | Ontario | Canada | ||
| The Ottawa Hospital Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34287262 | Background | 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. | |
| 40442096 | Background | 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. |
| Label | URL |
|---|---|
| The Rethinking Clinical Trials (REaCT) website | View source |
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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.
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Participants and investigators will not be blinded to treatment allocation as the study is only randomizing treatment schedule.
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| Evening administration of CDK4/6 inhibitor | Other | Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime. |
|
| Morning administration of ARPI | Other | Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time. |
|
| Evening administration of ARPI | Other | Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime. |
|
| 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. | 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. | 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. | Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years |
| Number of changes in treatment dose | 5 years |
| Number of treatment interruptions | 5 years |
| Number of treatment discontinuations | 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. | 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. | 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. | 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. | Baseline |
| Overall survival |
Overall survival is the time from randomization to death from any cause. Survival status (yes/no) will be checked throughout the study at the various timepoints outlined in the time frame. |
| 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years, 6-years post-randomization. |
| PSA reduction at 6 months | Cohort B only: prostate-specific antigen reduction. | 6 months |
| Recruiting |
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
|
| Saskatoon Cancer Centre | Not yet recruiting | Saskatoon | Saskatchewan | Canada |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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