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One-Week radiation may cut lymphedema risk in breast cancer patients

NCT ID NCT04228991

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a 1-week radiation course to a standard 3-week course for women with node-positive breast cancer. The goal is to see if the shorter treatment is just as effective at preventing cancer from coming back while reducing the risk of lymphedema (arm swelling). About 588 participants who had surgery will be followed for outcomes like recurrence, survival, and quality of life.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 588 people

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

Started

Feb 2021

Expected to finish

Dec 2030

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

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: 1. Newly diagnosed invasive carcinoma of the breast. 2. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.\* Note: \*Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible. 3. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery: * Neoadjuvant chemotherapy was not administered: pathologic stage T3N0,T1-3 N1-2\*\* \*\* patients with nodal micromets (N1mi) are eligible * Neoadjuvant chemotherapy was administered: clinical stage T3N0, T1-3, N1-2 and pathologic stage T0-3, N0-2† * Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive. Patients who are deemed node negative prior to chemotherapy but are node positive following chemotherapy are eligible. Patients who are node positive prior to chemotherapy and who have complete response in the lymph nodes are also eligible. 4. No evidence of metastatic disease. Exclusion Criteria: 1. Age \< 18 years. 2. Clinical stages T4 and/or N3. 3. Clinical lymphedema in the ipsilateral arm or breast/chest wall. 4. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.) 5. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.) 6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma. 7. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.) 8. Breast reconstruction. 9. Presence of known medical conditions that would preclude follow-up for 5 years. 10. Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy. 11. Known pregnancy or currently lactating. 12. Geographic inaccessibility for follow-up. 13. Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

breast neoplasm invasive breast carcinoma lymphedema

As listed by the trial registrant

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

Breast neoplasms Lymphedema Radiotherapy

Contacts and locations

Locations

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1, Canada

  • BC Cancer - Centre for the North

    Prince George, British Columbia, Canada

  • BC Cancer - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BC Cancer - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • BC Cancer - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5, Canada

  • CHU-de Québec-Université de Laval

    Québec, Quebec, Canada

  • CHUM - Centre Hospitalier de L'Universite de Montreal

    Montreal, Quebec, Canada

  • CIUSSS de l'Est-de-l'Île de Montréal, Hôpital, Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Hotel-Dieu de Lévis (CISSS CA)

    Lévis, Quebec, G6V 3Z1, Canada

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • London Regional Cancer Program

    London, Ontario, N6A 5W9, Canada

  • McGill University Health Centre-Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Northeast Cancer Centre, Health Sciences North

    Greater Sudbury, Ontario, P3E5J1, Canada

  • Princess Margaret Cancer Centre - UHN

    Toronto, Ontario, M5G 1E0, Canada

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Sherbrooke University Hospital Centre

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Sunnybrook Health Sciences Centre - Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.