Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance
NCT05754528 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-04-02
Summary
The goal of this randomized, pragmatic clinical trial is to evaluate an endocrine therapy dose-frequency escalation strategy and its effects on tolerability and compliance. Participants will be randomized to standard daily dosing of endocrine therapy or endocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily.
Conditions
Interventions
- DRUG
-
Standard of care administration of Endocrine therapy
Standard daily dosing of endocrine therapy. Defined as taking endocrine therapy every day from the start.
- DRUG
-
Dose-frequency escalation administration of Endocrine therapy
Endocrine therapy dose-frequency escalation. Defined as taking endocrine therapy every other day for 1 month and then daily.
Sponsors & Collaborators
-
Ottawa Hospital Research Institute
lead OTHER
Principal Investigators
-
Marie-France Savard, MD · Ottawa Hospital Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-28
- Primary Completion
- 2025-11-25
- Completion
- 2030-02-28
Countries
- Canada
Study Locations
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