Skipping lymph node surgery: a new frontier in breast cancer care?
NCT ID NCT07803081
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study follows 500 women with early-stage invasive breast cancer who had breast-conserving surgery without sentinel lymph node biopsy or other axillary surgery. All participants receive adjuvant radiotherapy as part of their routine care. Researchers will track cancer recurrence, survival, radiation side effects, and quality of life over five years. The goal is to understand whether omitting lymph node surgery is safe and how different radiotherapy approaches affect long-term outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adjuvant breast radiotherapy (whole-breast or partial-breast irradiation) delivered per routine clinical practice
- What this could lead to
- If successful, this study could clarify whether skipping sentinel lymph node biopsy is safe for certain early breast cancer patients, potentially sparing them from unnecessary surgery and its side effects.
- What could go wrong
- This is an observational study, not a randomized trial, so it cannot prove cause and effect. Results may be influenced by differences in patient characteristics or treatment choices, and longer follow-up is needed to confirm safety.
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.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 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.
Who is studied
Patients with histologically confirmed early-stage invasive breast cancer who have undergone breast-conserving surgery without sentinel lymph node biopsy or other axillary lymph node surgery and are scheduled to receive adjuvant radiotherapy. Eligible patients will have no evidence of distant metastasis on preoperative clinical and imaging evaluation and will be prospectively enrolled at participating institutions. Treatment decisions, including radiotherapy approach and systemic therapy, will follow routine clinical practice and will not be assigned by the study.
- Ages
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19 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 patients aged 19 years or older with histologically confirmed invasive breast cancer * Patients who have undergone breast-conserving surgery with curative intent * Patients who did not undergo axillary lymph node surgery, including sentinel lymph node biopsy, at the time of breast cancer surgery * No evidence of distant metastasis on clinical and imaging evaluation before surgery * Planned to receive adjuvant radiotherapy after breast-conserving surgery * Ability and willingness to provide written informed consent before study participation Exclusion Criteria: * Patients initially diagnosed with breast carcinoma in situ before surgery who did not undergo sentinel lymph node biopsy but were subsequently found to have invasive breast cancer on final surgical pathology * Receipt of neoadjuvant systemic therapy before breast cancer surgery * History of a malignancy other than breast cancer within 5 years before study enrollment, except adequately treated non-melanoma skin cancer or carcinoma in situ other than breast carcinoma in situ * Recurrent breast cancer * Bilateral breast cancer or inflammatory breast cancer * Prior radiotherapy to the ipsilateral breast or chest region * Patients considered by the investigator to be unsuitable for study participation or long-term follow-up
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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
RECRUITINGSeoul, 05649, South Korea
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