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Fewer radiation sessions may keep breast cancer at bay

NCT ID NCT06443359

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a shorter, more intense radiation schedule (hypofractionation) for women with breast cancer who have had surgery. The goal is to see if this approach is safe and effective at preventing cancer from coming back while reducing side effects like arm swelling. Fifty-six women will receive radiation to the breast or chest wall and nearby lymph nodes over about three weeks, and they will be followed for three years.

What this could mean

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

Active substance
hypofractionated radiation therapy
What this could lead to
If successful, this could offer a more convenient and equally safe radiation schedule for breast cancer patients, reducing treatment visits and long-term arm swelling.
What could go wrong
This is a small, early-phase study with only 56 participants, so results may not apply to all patients. There is still a risk of cancer recurrence or side effects like lymphedema.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

56 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Jul 2027

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: * Female * Age ≥ 18 years old * Life expectancy of \>5 years * ECOG (Zubrod) performance status 0-1 * Histologically confirmed invasive carcinoma of the breast, including ductal, lobular, mammary, medullary, and tubular histologies * Clinical T stage of cT0, cT1, cT2, or cT3 * Clinical N stage of cN0, cN1, or cN2a * Clinical M stage of cM0Definitive surgery must be performed (either partial mastectomy or mastectomy without immediate reconstruction) with negative surgical margins (defined as no invasive tumor or DCIS on ink). * Must have pathologic T stage of pT1, pT2, or pT3, or if receiving neoadjuvant chemotherapy, ypT0, ypTis, ypT1, ypT2, or ypT3 * Pathologic N stage of pN0, pN1, pN2a, or pN3a, or if receiving neoadjuvant chemotherapy, ypN0,ypN1, ypN2, or ypN3a) NOTE: any patient with clinically involved but undissected lymph nodes that would require a radiation boost will not be eligible. * The radiation oncologist is planning to treat the breast/chest wall and ipsilateral regional lymphatics (including the axillary, supraclavicular, and internal mammary chains) * Patient is able to understand and willing to sign an IRB approved written informed consent document * All dosimetric constraints outlined in protocol section 3.5 can be met Exclusion Criteria: * Clinical or pathologic T4 disease, including inflammatory breast cancer * Clinical N stage of cN2b, cN3 disease, pathologic N stage of pN2b, pN3b, or pN3c disease, or if receiving neoadjuvant chemotherapy, ypN2b, ypN3b, or ypN3c disease * Radiologic evidence of gross residual disease * History of prior ipsilateral breast cancer (invasive disease or DCIS) * Active or history of another malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix * Prior history of radiation therapy to the neck, breast, or thorax. Prior radioactive oral iodine is permitted. * History of active collagen vascular disease including systemic lupus erythematosis, scleroderoma, or dermatomyositis with an elevated CK level * Pregnancy, active breast feeding, or refusal or inability to use highly effective means of contraception in participants of child-bearing potential. * The patient is a prisoner.

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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.

Contacts and locations

Locations

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085, United States

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124, United States

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073, United States

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