Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance

NCT05754528 | Active Not Recruiting Phase 4

• 1 other identifier: REaCT-TEMPO
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer

Keywords

Endocrine Therapy; Endocrine Therapy Toxicity; Dose-frequency escalation

Outcome Measures

Primary Outcomes (1)

• 1-year adherence with prescribed endocrine therapy

  1-year adherence with prescribed endocrine therapy measured by the validated Five-item Medication Adherence Report Scale (MARS-5 score). The MARS-5 score can range from 5 to 25 indicating greater level of adherence. A participant will be considered adherent if they have a MARS-5 score of 23 and more (specificity and sensitivity maximized at this value). The adherence rate at 1-year will be calculated as the number of patients who are initially enrolled in the study. Participants who do not complete the 1-year MARS-5 questionnaire will be considered as non-adherent for the primary analysis of adherence rate.

  1 year after start of endocrine therapy

Secondary Outcomes (7)

• Adherence rates with prescribed endocrine therapy

  Through study completion, 5 years

• Persistence with prescribed endocrine therapy

  Through study completion, 5 years

• Endocrine toxicity and tolerability

  Through study completion, 5 years

• Patient health-related quality of life

  Through study completion, 5 years

• Endocrine therapy interruptions

  Through study completion, 5 years

Study Arms (2)

Standard daily dosing of endocrine therapy

ACTIVE COMPARATOR

Standard daily dosing of endocrine therapy

Drug: Standard of care administration of Endocrine therapy

Endocrine therapy dose-frequency escalation

EXPERIMENTAL

Endocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily.

Drug: Dose-frequency escalation administration of Endocrine therapy

Interventions

Standard of care administration of Endocrine therapy DRUG

Standard daily dosing of endocrine therapy. Defined as taking endocrine therapy every day from the start.

Standard daily dosing of endocrine therapy

Dose-frequency escalation administration of Endocrine therapy DRUG

Endocrine therapy dose-frequency escalation. Defined as taking endocrine therapy every other day for 1 month and then daily.

Endocrine therapy dose-frequency escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an early stage or locally advanced hormonal receptor positive breast cancer
• Plan to receive endocrine therapy
• Able to provide oral consent
• Willing and able to complete questionnaires as per study protocol

You may not qualify if:

• Metastatic cancer
• Adjuvant abemaciclib

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Related Links

• The Rethinking Clinical Trials (REaCT) website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marie-France Savard, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 6, 2023
• Study Start: July 28, 2023
• Primary Completion: November 25, 2025
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

CA (2)