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Morning or evening? study tests best time for breast cancer pill to ease side effects

NCT ID NCT04864405

Symptom relief Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether taking hormone therapy for breast cancer in the morning or evening reduces side effects and helps patients stay on treatment. 245 women with early-stage breast cancer were randomly assigned to take their medication either within an hour of waking or within an hour of bedtime. Researchers tracked changes in side effects and quality of life over 12 weeks using a standard questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endocrine therapy (hormone-blocking medication)
What this could lead to
If successful, this could help breast cancer patients choose the best time of day to take their medication to feel better and stick with treatment.
What could go wrong
This is a small, completed Phase 4 trial focused on side effects, not on curing cancer. The results may not apply to all patients or change standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

245 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, Canada

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4, Canada

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