Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
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
Trial design
Treatments tested in this trial
- Morning administration of CDK4/6 inhibitor
- Evening administration of CDK4/6 inhibitor
- Morning administration of ARPI
- Evening administration of ARPI
Treatment groups
50 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov