Metastatic Breast Cancer, Metastatic Prostate Cancer
Conditions
Keywords
Chronotherapy, breast cancer, prostate cancer, endocrine therapy, metastatic cancer
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).
Interventions
OTHERMorning 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.
OTHEREvening administration of CDK4/6 inhibitor
Evening administration of cyclin-dependent kinase (CDK) 4/6 inhibitor defined as, within one hour of the participant bedtime.
OTHERMorning administration of ARPI
Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
OTHEREvening administration of ARPI
Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and investigators will not be blinded to treatment allocation as the study is only randomizing treatment schedule.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: accrual per site | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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 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. |
| 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 | 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. |
| 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 | 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years | The number of participants in Cohort A that experience QTc prolongation, neutropenia, febrile neutropenia, hepatobiliary function. |
| Cohort B's adverse events of interest | 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years | The number of participants in Cohort B that experience hypertension, hyperglycemia, rash, hypothyroidism, fatigue. |
| Adherence to treatment | 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years | 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. |
| Participant preference in dose timing | Baseline | 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. |
Countries
Canada
Contacts
CONTACTLisa Vandermeer, MSc
CONTACTDeanna Saunders, MSc
PRINCIPAL_INVESTIGATORMarie-France Savard, MD
The Ottawa Hospital
PRINCIPAL_INVESTIGATORAna-Alicia Beltran-Bless, MD
The Ottawa Hospital
Outcome results
None listed