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Could skipping a lymph node check spare women from unneeded surgery?

NCT ID NCT02271828

Disease control Sponsor: Maastricht University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial asks whether women with early breast cancer who have lumpectomy and whole-breast radiation can safely skip the sentinel lymph node procedure, a biopsy of the first lymph node under the arm. The procedure helps check if cancer has spread, but it can cause arm swelling and pain. Researchers compare women who get the standard biopsy with those who skip it, tracking whether cancer returns in the lymph nodes over time. If skipping the biopsy is just as safe, many women could avoid extra surgery and enjoy a better quality of life.

What this could mean

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

Active substance
Sentinel lymph node procedure (surgical removal of the first lymph node to check for cancer spread)
What this could lead to
If omitting the sentinel node procedure proves safe, many women with early breast cancer could avoid an extra surgery, reducing arm swelling and pain while keeping cancer control.
What could go wrong
The trial is large but not yet conclusive. If the omission leads to a slightly higher chance of cancer returning in the lymph nodes, it would not be adopted. Also, the procedure is standard, so changing practice requires strong evidence.

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

1,644 people

The number who actually took part.

Started

May 2015

Finished

Aug 2026

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 * Aged 18 years or older * Pathologically confirmed invasive breast carcinoma * A clinical T1-2 tumor * Will be treated with lumpectomy and whole breast radiotherapy * Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology) * Written informed consent Exclusion Criteria: * Clinically node positive pre-operative * Bilateral breast cancer * Evidence of metastatic disease * History of invasive breast cancer * Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi) * Pregnant or nursing * Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies \> 5 years before randomization * Unable or unwilling to give informed consent

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Conditions

The condition(s) this trial relates to.

breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms

Contacts and locations

Locations

  • Alrijne

    Leiden, Netherlands

  • Amphia ziekenhuis

    Breda, Netherlands

  • Canisius-Wilhelmina ziekenhuis

    Nijmegen, Netherlands

  • Catharina ziekenhuis

    Eindhoven, Netherlands

  • Deventer ziekenhuis

    Deventer, Netherlands

  • Diakonessenhuis

    Utrecht, Netherlands

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Groene Hart ziekenhuis

    Gouda, Netherlands

  • Haga ziekenhuis

    The Hague, Netherlands

  • Isala Klinieken

    Zwolle, Netherlands

  • Jeroen Bosch ziekenhuis

    's-Hertogenbosch, Netherlands

  • Laurentius ziekenhuis

    Roermond, Netherlands

  • Maastricht University Medical Centre+

    Maastricht, Limburg, 6202 AZ, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, Netherlands

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, Netherlands

  • Radboud UMC

    Nijmegen, Netherlands

  • Rijnstate

    Arnhem, Netherlands

  • Spaarne Gasthuis

    Haarlem, Netherlands

  • St. Antonius ziekenhuis

    Nieuwegein, Netherlands

  • UMC Groningen

    Groningen, Netherlands

  • UMC Utrecht

    Utrecht, Netherlands

  • Zuwehofpoort ziekenhuis

    Woerden, Netherlands

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