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New study questions need for hormone therapy in older breast cancer patients

NCT ID NCT04921137

Knowledge-focused 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether women aged 70 and older with low-risk breast cancer can safely skip hormone therapy after surgery. Current guidelines recommend at least 5 years of hormone therapy, but older patients may face more side effects with less benefit. The trial will compare outcomes like survival, cancer return, and quality of life between those who take hormone therapy and those who do not.

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

May 2036

An estimate. End dates often move.

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

70 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: * New invasive estrogen and/or progesterone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) invasive breast carcinoma diagnosis as per ASCO-CAP guidelines * The primary tumour characteristics are either: Grade 1 and ≤3 cm on microscope exam, OR Grade 2 and ≤2 cm on microscope exam, OR Grade 3 and ≤1 cm on microscope exam * Treated with standard loco-regional therapy: breast conserving surgery followed by adjuvant radiotherapy OR total mastectomy * Axillary node-negative (cN0 or pN0) * Able to provide oral consent and complete questionnaires in French or English as per study protocol Exclusion Criteria: * Metastatic cancer

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allan Blair Cancer Centre

    ACTIVE_NOT_RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

  • Cross Cancer Institute

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • London Health Sciences Centre

    ACTIVE_NOT_RECRUITING

    London, Ontario, N6C 2R5, Canada

  • Oak Valley Health

    ACTIVE_NOT_RECRUITING

    Markham, Ontario, L3P 7P3, Canada

  • Saskatoon Cancer Centre

    ACTIVE_NOT_RECRUITING

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1H8L6, Canada

  • Thunder Bay Regional Health Sciences Centre

    ACTIVE_NOT_RECRUITING

    Thunder Bay, Ontario, P7B 6V4, Canada

  • Waterloo Regional Health Network

    ACTIVE_NOT_RECRUITING

    Kitchener, Ontario, N2G 1G3, Canada

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