Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers

Официальное название

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)

Обзор

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).

Вмешательства

• Другое 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.
• Другое 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.
• Другое Morning administration of ARPI
  Morning administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient wake up time.
• Другое Evening administration of ARPI
  Evening administration of androgen receptor pathway inhibitors (ARPI) defined as, within one hour of the patient bedtime.

Первичные конечные точки

• Feasibility: accrual per site [Срок оценки: 1 year]
• Feasibility: participation rate [Срок оценки: The accrual period, approximately 1 year]
• Feasibility: number of participants who received allocated intervention [Срок оценки: 4 weeks]

Вторичные конечные точки (11)

• Health-related quality of life: Functional Assessment of Cancer Therapy-General [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline and 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years]
• Number of changes in treatment dose [Срок оценки: 5 years]
• Number of treatment interruptions [Срок оценки: 5 years]
• Number of treatment discontinuations [Срок оценки: 5 years]
• Cohort A's adverse events of interest [Срок оценки: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years]
• Cohort B's adverse events of interest [Срок оценки: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years]
• Adherence to treatment [Срок оценки: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years]
• Participant preference in dose timing [Срок оценки: Baseline]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

• Waterloo Regional Health Network — Kitchener
• The Ottawa Hospital Cancer Centre — Ottawa
• Saskatoon Cancer Centre — Saskatoon

Публикации

• 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. PMID 34287262
• 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. PMID 40442096

Идентификаторы

NCT: NCT07252726 · REaCT-CHRONO-MetBP Pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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