Can less radiation be just as effective for early breast cancer?
NCT ID NCT07757958
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial is testing whether treating only part of the breast with radiation is as effective as treating the whole breast in women with early-stage, low-risk breast cancer. Participants are women aged 40 and older who had breast-conserving surgery and did not have a sentinel lymph node biopsy. The study compares recurrence rates, side effects, and quality of life between the two radiation approaches over five years.
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 (partial breast irradiation compared to whole breast irradiation)
- What this could lead to
- If partial breast irradiation works as well as whole breast irradiation, it could offer a shorter, more targeted treatment with fewer side effects for many women with early breast cancer.
- What could go wrong
- This is a large trial, but results are not yet available. Partial breast irradiation might not control cancer as effectively as whole breast irradiation in the long term, and individual outcomes may vary.
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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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 520 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2036
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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40 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 ≥40 years with histologically confirmed unilateral invasive breast cancer. * No suspicious nodal metastasis on preoperative axillary ultrasound (cN0). * Single lesion in the affected breast on preoperative breast ultrasound and mammography. * Treated with breast-conserving surgery with pathologically negative margins for the invasive tumor. * Sentinel lymph node biopsy not performed at surgery (pNx). * Maximum diameter of invasive tumor ≤2 cm on final pathology (pT1). * Histologic grade 1 or 2. * Signed informed consent prior to enrollment. Exclusion Criteria: * History of malignancy other than breast cancer within 5 years (except adequately treated non-melanoma skin cancer, or carcinoma in situ excluding breast carcinoma in situ). * Preoperative diagnosis of carcinoma in situ without axillary nodal sampling, subsequently diagnosed as invasive breast cancer on final pathology with SLNB omitted. * Lymphovascular invasion present (LVI+). * Multifocal or multicentric tumor in the same breast confirmed radiologically or pathologically. * Bilateral or inflammatory breast cancer. * Prior radiotherapy to the breast or thorax. * Confirmed pathogenic or likely pathogenic variant in a hereditary breast cancer gene (including BRCA1/2). * Recurrent breast cancer.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Samsung Medical Center
Seoul, 05649, South Korea
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