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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754528 on ClinicalTrials.gov