Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Other: Morning administration of endocrine therapy; Other: Evening administration of endocrine therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04864405

REaCT-CHRONO

Details and patient eligibility

About

Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.

Full description

Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Compliance is defined as the degree or extent of conformity to the recommended administration by the provider, whereas persistence refers to the act of continuing treatment for a certain prescribed duration. Treatment adherence is especially important in breast cancer, as early cessation or reduced compliance to hormonal therapy are associated with reduced disease-free survival and increased mortality. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Metastatic cancer
• Previous endocrine therapy for breast cancer
• Plan to receive adjuvant abemaciclib

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

Morning administration of endocrine therapy

Active Comparator group

Description:

Administration of endocrine therapy defined as, within one hour of the patient wake up time

Treatment:

Other: Morning administration of endocrine therapy

Evening administration of endocrine therapy

Active Comparator group

Description:

Administration of endocrine therapy defined as, within one hour of the patient bed time

Treatment:

Other: Evening administration of endocrine therapy