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One shot of radiation could replace weeks of treatment for some breast cancers

NCT ID NCT05350722

Disease control Sponsor: Amsterdam UMC, location VUmc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial investigates whether a single, high dose of MRI-guided radiation given before surgery can completely eliminate low-risk breast cancer. Women aged 50 and older with small, early-stage tumors receive one radiation dose, then wait 6 to 12 months before surgery to see if the cancer is gone. The goal is to find a simpler, less invasive treatment option that might avoid the need for standard radiation or even surgery.

What this could mean

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

Active substance
single dose ablative radiotherapy
What this could lead to
If successful, this approach could allow some low-risk breast cancer patients to avoid surgery or standard radiation, reducing treatment burden.
What could go wrong
This is an early-phase trial with only 100 participants, so results may not apply broadly. The single dose may not fully eliminate the tumor, and long-term safety is unknown.

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 100 people

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

Started

Aug 2022

Expected to finish

Dec 2037

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

40 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: * WHO performance scale ≤2. * Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI. * Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible. * Tumor size as assessed on MRI. * On tumor biopsy: * Bloom-Richardson grade 1 or 2. * Non-lobular invasive histological type carcinoma. * LCIS or (non-extensive) DCIS is accepted. * ER positive tumor receptor. * HER2 negative tumor. * Tumor-negative sentinel node (excluding isolated tumor cells). * Adequate communication and understanding skills of the Dutch language. Exclusion Criteria: * Legal incapacity. * BRCA1, BRCA2 or CHEK2 gene mutation. * Distant metastasis. * Previous history of breast cancer or DCIS. * Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. * For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion. * Collagen synthesis disease. * Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography). * Invasive lobular carcinoma. * MRI absolute contraindications as defined by the Department of Radiology. * Nodal involvement with cytological or histological confirmation. * Indication for treatment with (neo-)adjuvant chemotherapy. * Non-feasible dosimetric RT plan.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Pathologic Complete Response

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

    7 sites in 2 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

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    RECRUITING

    Nijmegen, Netherlands

  • Flevoziekenhuis

    RECRUITING

    Almere Stad, Netherlands

  • GenesisCare

    NOT_YET_RECRUITING

    Sydney, Australia

  • Radboud UMC

    RECRUITING

    Nijmegen, Netherlands

  • Zaans Medisch Centrum

    RECRUITING

    Zaandam, Netherlands

  • Ziekenhuis Amstelland

    RECRUITING

    Amstelveen, Netherlands

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