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Major trial tests cutting radiation for breast cancer – could spare thousands from side effects

NCT ID NCT05634889

Disease control Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for women with early-stage breast cancer that has spread to 1-2 lymph nodes. It tests whether skipping radiation to the lymph nodes can reduce side effects and improve quality of life without increasing the risk of cancer coming back. About 1,350 participants will be randomly assigned to receive either standard radiation or a reduced plan that avoids lymph node treatment. The goal is to see if the gentler approach is just as effective at preventing recurrence over five years.

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

About 1,350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2033

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: 1. Primary unifocal or multifocal invasive breast cancer T1-T2. 2. Clinically N0. 3. Macrometastasis (\>2mm) in 1-2 lymph nodes at sentinel node biopsy. 4. Oral and written consent. 5. Age ≥ 18 years. 6. All resection margins are tumor free (no tumor on ink). 7. Primary tumor ER-positive, HER2-negative. Exclusion Criteria: 1. Regional or distant metastases outside the ipsilateral axilla. 2. Previous RT towards the planned target area, i.e. the ipsilateral chest/lymph nodes. 3. Neoadjuvant systemic therapy. 4. Axillary lymph node dissection or other previous axillary surgery on the affected side. 5. Prior history of invasive breast cancer. 6. Pregnancy. 7. Bilateral invasive breast cancer. 8. Contraindication for radiotherapy or systemic treatment. 9. Inability to absorb or understand the contents of the informed consent form; for example, through disability, inadequate language skills or dementia. 10. Other invasive cancer within 5 years prior to breast cancer diagnosis

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Bergen

    RECRUITING

    Bergen, Norway

  • Bodø

    NOT_YET_RECRUITING

    Bodø, Norway

  • Gjövik

    RECRUITING

    Gjøvik, Norway

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Finland

  • Kristiansand

    RECRUITING

    Kristiansand, Norway

  • Lahti Hospital

    NOT_YET_RECRUITING

    Lahti, Finland

  • Oslo

    RECRUITING

    Oslo, Norway

  • Region Gävleborg

    RECRUITING

    Gävle, Sweden

  • Region Halland

    RECRUITING

    Halmstad, Sweden

  • Region Jönköping

    RECRUITING

    Jönköping, Sweden

  • Region Kalmar län

    RECRUITING

    Kalmar, Sweden

  • Region Kronoberg

    RECRUITING

    Vaxjo, Sweden

  • Region Skåne

    RECRUITING

    Lund, Sweden

  • Region Stockholm

    RECRUITING

    Stockholm, Sweden

  • Region Sörmland

    RECRUITING

    Eskilstuna, 24751, Sweden

  • Region Uppsala

    NOT_YET_RECRUITING

    Uppsala, Sweden

  • Region Värmland

    RECRUITING

    Karlstad, Sweden

  • Region Västerbotten

    RECRUITING

    Umeå, Sweden

  • Region Västernorrland

    RECRUITING

    Sundsvall, Sweden

  • Region Västmanland

    RECRUITING

    Västerås, Sweden

  • Region Västra Götaland

    RECRUITING

    Gothenburg, Sweden

  • Region Västragötaland

    RECRUITING

    Borås, Sweden

  • Region Västragötaland

    RECRUITING

    Skövde, Sweden

  • Region Örebro

    RECRUITING

    Örebro, Sweden

  • Region Östergötland

    RECRUITING

    Linköping, Sweden

  • Stavanger

    RECRUITING

    Stavanger, Norway

  • Tromsø

    RECRUITING

    Tromsø, Norway

  • Trondheim

    RECRUITING

    Trondheim, Norway

  • Turku University Hospital

    NOT_YET_RECRUITING

    Turku, Finland

  • Ålesund

    RECRUITING

    Ålesund, Norway

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