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Clinical trial

A Pragmatic Randomised, Trial Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance (REaCT-TEMPO)

ID
Name
REaCT-TEMPO
Description
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.
Trial arms
Trial start
2023-07-28
Estimated PCD
2025-07-01
Trial end
2029-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Standard of care administration of Endocrine therapy
Standard daily dosing of endocrine therapy. Defined as taking endocrine therapy every day from the start.
Arms:
Standard daily dosing of endocrine therapy
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.
Arms:
Endocrine therapy dose-frequency escalation
Size
240
Primary endpoint
1-year adherence with prescribed endocrine therapy
1 year after start of endocrine therapy
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Metastatic cancer * Adjuvant abemaciclib
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}
Updated at
2023-08-07

1 organization

2 products

1 indication

Organization
Ottawa Hospital Research Institute
Product
Endocrine Therapy
Indication
Breast Cancer
Product
Endocrine therapy