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Genetic test may spare thousands of women from unnecessary radiation

NCT ID NCT04797299

Disease control Sponsor: Ontario Clinical Oncology Group (OCOG) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study looks at whether women over 45 with a low-risk type of early breast cancer (DCIS) can avoid radiation after breast-conserving surgery. A genetic test helps identify those with a very low chance of the cancer coming back. The goal is to see if skipping radiation is safe and still keeps the cancer from returning.

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.

Participants

About 526 people

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

Started

Nov 2022

Expected to finish

Nov 2035

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.

Who is studied

Prospective cohort study conducted in Canada in women with a low risk DCIS following breast conserving surgery who are candidates for radiation. Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment

Ages

46 years and older

Sex

Female participants only

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: 1. Female patient \> 45 years of age with DCIS without microinvasion. 2. Tumour size ≤ 2.5cm. 3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\* \* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins. 4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%. Exclusion Criteria: 1. Multifocal DCIS. 2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast. 3. Synchronous or previous invasive or non-invasive breast cancer. 4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers. 5. ECOG performance status ≥3. 6. Life expectancy \<10 years. 7. Geographic inaccessibility for follow-up.

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Conditions

The condition(s) this trial relates to.

ductal breast carcinoma in situ

As listed by the trial registrant

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

DCIS

How to take part

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

  1. The places running it

    24 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

    RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

  • Arthur J.E. Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • BC Cancer - Abbotsford Centre

    RECRUITING

    Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

  • BC Cancer - Centre for the North (Prince George)

    RECRUITING

    Prince George, British Columbia, V2M 7E9, Canada

  • BC Cancer - Fraser Valley Centre

    RECRUITING

    Surrey, British Columbia, V3V 1Z2, Canada

  • BC Cancer - Vancouver Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BC Cancer - Victoria

    RECRUITING

    Victoria, British Columbia, V8R 6V5, Canada

  • CHUM - Centre Hospitalier de L'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2L 4M1, Canada

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cape Breton Cancer Centre

    RECRUITING

    Sydney, Nova Scotia, B1P 1P3, Canada

  • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières

    RECRUITING

    Trois-Rivières, Quebec, G8Z 3R9, Canada

  • Centre intégré de cancérologie du CHU de Québec - Université Laval

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)

    RECRUITING

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Jewish General Hospital

    WITHDRAWN

    Montreal, Quebec, H3T 1E2, Canada

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • London Regional Cancer Program

    RECRUITING

    London, Ontario, N6A 4L6, Canada

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • QE II HSC - Nova Scotia Cancer Centre

    RECRUITING

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Regional Cancer Care, Thunder Bay Regional Health Sciences Centre

    RECRUITING

    Thunder Bay, Ontario, P7B 6V4, Canada

  • Royal Victoria Regional Health Centre

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Saskatoon Cancer Centre

    RECRUITING

    Saskatoon, Saskatchewan, S7N4H4, Canada

  • Sunnybrook Health Science Centre -Odette Cancer Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • University Health Network - Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Windsor Regional Cancer Centre

    RECRUITING

    Windsor, Ontario, N8W 2X3, Canada

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