Fewer radiation sessions may keep breast cancer at bay
NCT ID NCT06443359
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
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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
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56 people
The number who actually took part.
- Started
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Nov 2018
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
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Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
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Other studies related to the condition(s) this trial covers.
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