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NCT Number: NCT07252726

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

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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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Waterloo Regional Health Network, Kitchener, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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 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.

  2. 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 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.

  3. 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 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.

  4. 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

    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.

  5. Number of changes in treatment dose

    Time frame: 5 years

  6. Number of treatment interruptions

    Time frame: 5 years

  7. Number of treatment discontinuations

    Time frame: 5 years

  8. Cohort A's adverse events of interest

    Time frame: 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.

  9. Cohort B's adverse events of interest

    Time frame: 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.

  10. Adherence to treatment

    Time frame: 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.

  11. Participant preference in dose timing

    Time frame: 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.

Other outcomes

  1. Time to second-line systemic treatment

    Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years

    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.

  2. Overall survival

    Time frame: 4-, 12-, 26-, 52-weeks, 2-years, 3-years, 4-years, 5-years, 6-years post-randomization.

    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.

  3. PSA reduction at 6 months

    Time frame: 6 months

    Cohort B only: prostate-specific antigen reduction.

Study contacts

Contact information is provided by the study sponsor or research team.

Deanna Saunders, MSc

CONTACT

[email protected]

613-737-7700

Lisa Vandermeer, MSc

CONTACT

[email protected]

613-737-7700

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2033
First posted
Nov 28, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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