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Major trial tests whether skipping armpit surgery after sentinel node cancer is safe for breast cancer patients

NCT ID NCT02240472

Disease control Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial investigates whether breast cancer patients with cancer in 1-2 sentinel lymph nodes can safely avoid additional armpit surgery (axillary clearance). The study compares survival and cancer recurrence in patients who have the extra surgery versus those who do not. The goal is to see if skipping surgery reduces side effects like arm swelling and pain without harming long-term outcomes. Participants are women with early-stage breast cancer and no signs of armpit involvement before surgery.

What this could mean

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

Active substance
omission of axillary clearance (no further armpit surgery after sentinel node biopsy)
What this could lead to
If successful, this could show that many breast cancer patients can safely avoid extra armpit surgery, reducing side effects like arm swelling and pain without harming survival.
What could go wrong
The trial is large but observational in design, and earlier studies had mixed results. There is a small risk that skipping surgery might increase cancer recurrence in the armpit over the long term.

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

2,766 people

The number who actually took part.

Started

Jan 2015

Expected to finish

Dec 2031

An estimate. End dates often move.

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

Anyone

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: * Patients with invasive breast cancer (T1-T3) * N0 on palpation * Preoperative ultrasound performed * Macrometastasis in 1-2 sentinel lymph nodes * The patient must have provided oral and written consent * Age ≥ 18 years Exclusion Criteria: * Metastases outside of the ipsilateral axilla * Prior history of invasive breast cancer * Pregnancy * Bilateral breast cancer if one side meets exclusion criteria * Medical contraindication for radiotherapy or systemic treatment * Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma Lymphatic Metastasis

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, Denmark

  • Aarhus University Hospital

    Aarhus, Denmark

  • Akademiska Sjukhuset

    Uppsala, Sweden

  • Athens University Hospital

    Athens, Greece

  • Blekinge sjukhuset

    Karlskrona, Sweden

  • Central Hospital Kristianstad

    Kristianstad, Sweden

  • Gävle sjukhus

    Gävle, Sweden

  • Hallands sjukhus

    Halmstad, Sweden

  • Helsingborg lasarett

    Helsingborg, Sweden

  • Kalmar sjukhus

    Kalmar, Sweden

  • Karlstad sjukhus

    Karlstad, Sweden

  • Karolinska University Hospital

    Stockholm, Sweden

  • Linköping University Hospital

    Linköping, Sweden

  • Länssjukhuset Ryhov

    Jönköping, Sweden

  • Malmö/Lund University Hospital

    Lund, Sweden

  • Odense University Hospital

    Odense, Denmark

  • Randers Regionshospitalet

    Randers, Denmark

  • Regionshospitalet Viborg

    Viborg, Denmark

  • Rigshospitalet

    Copenhagen, Denmark

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Skaraborgs sjukhus

    Skövde/Lidköping, Sweden

  • Southern Gerenal Hospital

    Stockholm, Sweden

  • St. Görans Hospital

    Stockholm, Sweden

  • Sundsvall länssjukhus

    Sundsvall, Sweden

  • Sydvestjysk Sygehus

    Esbjerg, Denmark

  • Sygehus Lillebaelt

    Lillebaelt, Denmark

  • Sygehus Sonderjylland

    Aabenraa, Denmark

  • Uddevalla sjukhus

    Uddevalla, Sweden

  • Umeå University Hospital

    Umeå, Sweden

  • Varbergs sjukhus

    Varberg, Sweden

  • Västervik Hospital

    Västervik, Sweden

  • Västerås Central Hospital

    Västerås, Sweden

  • Örebro University Hospital

    Örebro, Sweden

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