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Could a One-Week radiation blast beat three weeks for breast cancer?

NCT ID NCT06559540

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial compares a new ultra-short radiation schedule (5 sessions over 1 week) to the current standard (15-16 sessions over 3 weeks) for women with node-positive breast cancer. The goal is to see if the shorter course is just as effective at controlling cancer while causing fewer long-term side effects like arm swelling or heart damage. About 220 participants who have had surgery will be randomly assigned to one of the two radiation plans.

What this could mean

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

Active substance
radiation therapy
What this could lead to
If successful, this could offer a shorter, more convenient radiation schedule for node-positive breast cancer patients with fewer serious side effects.
What could go wrong
This is a phase 2 trial with only 220 participants, so results are preliminary. The ultra-short schedule may cause unexpected toxicity in the lymph node area.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 220 people

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

Started

Aug 2024

Expected to finish

Apr 2034

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

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: * Histologically confirmed invasive carcinoma of the breast. Metaplastic breast cancer is allowed. * AJCC 8th Edition Stage: cT1-3 primary tumor. cN1-2 or pN1-2. * Biopsy-proven involved axillary node(s) (either at baseline and/or at time of surgery). * Undergone either partial mastectomy (with negative final histologic margins (defined as no tumor on ink, after initial surgery or re-excision)) or mastectomy (with negative histologic margins defined as tumor (either invasive or in situ disease) \> 2 mm from the final margin). * Nodal surgery with either sentinel lymph node biopsy or axillary lymph node dissection. Effort to recover the original biopsy-proven node should be performed at time of surgery. * Systemic therapy (chemotherapy and/or endocrine therapy) should be administered as per standard of care and recommendation of medical oncology. Neoadjuvant and/or adjuvant systemic therapy is allowed. Concurrent endocrine therapy, anti-HER2 therapy, and immunotherapy during RT is allowed. * All radiation therapy must be planned to be delivered at BJH or a Siteman satellite location. * Female. * Age ≥ 18 years at diagnosis. * ECOG Zubrod performance status 0 or 1. * English speaker. * Able to understand and willing to sign IRB-approved written informed consent document. Exclusion Criteria: * Presence of distant metastases. * Diagnosis of nonepithelial breast malignancies such as sarcoma or lymphoma. * Diagnosis of bilateral breast cancer. * AJCC cT4 disease, pT4 disease, or any skin involvement on exam or pathology, including dermal LVSI. * Presence of palpable or radiographically suspicious supraclavicular, infraclavicular, or internal mammary nodes. * Prior radiation therapy which would have any overlap with current radiation therapy plan. * Diagnosis of prior breast cancer or diagnosis of current breast cancer more than one year prior to enrollment. * Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis. * Diagnosis of a coexisting medical condition which limits life expectancy to \< 2 years. * Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational treatment. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial. * Time between last breast cancer surgery to RT simulation is greater than 10 weeks, or time between completion of chemotherapy to RT simulation is greater than 8 weeks, whichever is performed last prior to RT. * Planning to undergo concurrent chemotherapy. * Pregnancy, which will be excluded prior to simulation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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