Can a tiny clip spare breast cancer patients full lymph node removal?
NCT ID NCT07828925
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are studying a technique to remove fewer lymph nodes in women with breast cancer that has spread to the lymph nodes and who receive chemotherapy before surgery. The approach uses a clip placed in the affected node to guide surgeons during a selective axillary dissection. The study tracks whether the clipped node matches the sentinel node and how often patients avoid a full node removal. About 105 women will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If the clip reliably marks the right node, doctors could remove fewer lymph nodes during surgery, which may lower the risk of arm swelling and nerve problems after breast cancer treatment.
- What could go wrong
- This is an observational study, not a randomized trial, so it can show patterns but cannot prove that selective dissection is as safe as standard full dissection. The technique may miss cancer in other nodes, and the results may not apply to all patients.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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105 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Sep 2020
- 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
Female Patients in both pre and post menopausal stage with a diagnosis of Lymphonode Positive Breast Cancer that have to undergo to neoadjuvant chemotherapy
- 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: * Age\>= 18 years * Female sex * Diagnosis of Lymph Node- Positive (cN+) Breast Cancer through core needle biopsy, cT1-3 (multifocal too) * Absence of distant metastases (M0) * Patients that will undergo to NACT Exclusion Criteria: * Previous diagnosis of Breast Cancer * Previous Breast and/or Axillary Surgery * Pregnancy * Inflammatory Breast Cancer (cT4) * Patients that will not undergo to NACT
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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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Radiology Department- Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
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