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 quali

Trial Details

NCT ID
NCT07252726
Phase
PHASE4
Sponsor
Ottawa Hospital Research Institute
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Morning administration of CDK4/6 inhibitor
  • Evening administration of CDK4/6 inhibitor
  • Morning administration of ARPI
  • Evening administration of ARPI
Locations (sample)
  • Kitchener, Ontario, Canada|43.42537,-80.5112
  • Ottawa, Ontario, Canada|45.41117,-75.69812
  • Saskatoon, Saskatchewan, Canada|52.13238,-106.66892

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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