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Recruiting NCT07252726

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

Phase IV Interventional Metastatic Breast Cancer Metastatic Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Morning administration of CDK4/6 inhibitor, Evening administration of CDK4/6 inhibitor, Morning administration of ARPI, Evening administration of ARPI.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer, Metastatic Prostate Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

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

Primary outcome measures

  • Feasibility: accrual per site [Time frame: 1 year]
  • Feasibility: participation rate [Time frame: The accrual period, approximately 1 year]
  • Feasibility: number of participants who received allocated intervention [Time frame: 4 weeks]
Secondary outcome measures (11)
  • 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]

Eligibility 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) 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • Waterloo Regional Health Network — Kitchener
  • The Ottawa Hospital Cancer Centre — Ottawa
  • Saskatoon Cancer Centre — Saskatoon

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. 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

Identifiers

NCT: NCT07252726 · REaCT-CHRONO-MetBP Pilot

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗