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Can targeted radiation extend control in metastatic breast cancer?

NCT ID NCT05377047

Disease control Sponsor: Vastra Gotaland Region 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether adding stereotactic ablative radiotherapy (SABR) to standard systemic therapy helps people with oligometastatic breast cancer, meaning cancer that has spread to only a few sites. The trial enrolls adults with 1 to 5 metastases in up to two organs. Participants receive either SABR plus systemic therapy or systemic therapy alone as their first treatment. The main goal is to see if the combination delays cancer progression.

What this could mean

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

Active substance
stereotactic ablative radiotherapy (SABR), a precise high-dose radiation treatment
What this could lead to
If adding SABR works, it could become a new first-line option that delays cancer progression for people with a limited number of breast cancer metastases.
What could go wrong
This is a phase 3 trial, so results are not yet known. SABR carries risks of radiation toxicity, and adding it may not improve outcomes over systemic therapy alone.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 345 people

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

Started

Sep 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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. Histologically or cytological confirmed recurrent OMBC. 2. Age ≥18 years old. 3. OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT. 4. Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease. 5. Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment. 6. Patients with local recurrence and OMBC must have a controlled local recurrence. 7. ECOG/WHO 0-2. 8. Life expectancy \> 6 months. 9. Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred). 10. Symptomatic bone metastases are allowed if ablative therapy can be delivered. 11. Adequate organ function for the planned treatment according to local guide-lines. 12. For patients with liver metastasis: * No cirrhosis or hepatitis * Hepatic function: * Total bilirubin level \< 3.0 x institutional ULN * ALT, AST, GGT, and alkaline phosphatase levels \< 3.0 x institutional ULN * Albumin \> 2.5 mg/dL * Metastasis not adjutant to stomach or small bowel. 13. For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of \> 60mL/min. 14. Toxicities from previous adjuvant therapies (excluding alopecia) must have recovered to grade 1 (defined by CTCAE 5.0). Stable grade 2 peripheral neuropathy are considered individually by the investigator. 15. Negative pregnancy test within 14 days prior to start of treatment\*. 16. If childbearing potential, willing to use an effective form of contraception\*. 17. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. 18. Signed informed consent and willingness to follow the trial procedures. Exclusion Criteria: 1. \> 1 line of systemic treatment for OMBC due to previous progressing disease (previous treatment of isolated local recurrences with a 2nd adjuvant treatment not included). Change due to toxicity allowed. 2. Oligometastases in brain. 3. Malignant pleural effusion or ascites. 4. Metastasis growth that involves \> 3 vertebra and adjacent spinal cord, spine instability or neurological deficit resulting from compression, 25% spinal canal compromise or progressive neurological deficit. 5. Unable to undergo imaging by either CT scan or MRI. 6. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance. 7. Pregnancy or breast-feeding. 8. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer stage IV Oligometastatic disease

How to take part

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

  1. The places running it

    19 sites in 6 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

  • Azienda Ospedaliero - Universitaria Careggi

    RECRUITING

    Florence, 3 50134, Italy

  • Bon Secours Cork In Partnership with UPMC Hillman Cancer Centre

    RECRUITING

    Cork, T12 DV56, Ireland

  • Cork University Hospital

    RECRUITING

    Cork, T12 DC4A, Ireland

  • Haukeland University Hospital

    RECRUITING

    Bergen, 5021, Norway

  • Humanitas Cancer Centre

    RECRUITING

    Milan, Italy

  • Institute of Oncology Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

  • Istituto Nationale Tumori (INT)

    RECRUITING

    Milan, Italy

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Region Stockholm, 17176, Sweden

  • Norrlands University Hospital

    RECRUITING

    Umeå, Region Västerbotten, 901 85, Sweden

  • Oslo University Hospital, Radiumhospitalet

    RECRUITING

    Oslo, 0424, Norway

  • Ryhov County Hospital

    RECRUITING

    Jönköping, Region Jönköpings Län, 551 85, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Västra Götalandsregionen, 41345, Sweden

  • Sheba Medical Center Institute of Oncology

    RECRUITING

    Tel Aviv, 5265601, Israel

  • Skånes University Hospital

    RECRUITING

    Malmö, Region Skåne, Sweden

  • St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital Dublin, St James Hospital Dublin and Beaumont Hospital Dublin

    RECRUITING

    Dublin, Ireland

  • St. Olavs Hospital

    RECRUITING

    Trondheim, 7006, Norway

  • Universitetssykehuset Nord-Norge

    RECRUITING

    Tromsø, 9019, Norway

  • University Hospital Galway (UHG)

    RECRUITING

    Galway, H91 YR71, Ireland

  • Örebro University Hospital

    RECRUITING

    Örebro, Region Örebro Län, SE-701 85, Sweden

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