RecruitingPhase 3NCT05377047

Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

Treatment of Oligometastatic Breast Cancer - a Randomised Phase 3 Trial Comparing Stereotactic Ablative Radiotherapy and Systemic Treatment With Systemic Treatment Alone as 1st Line Treatment

Sponsor

Vastra Gotaland Region

Enrollment

345 participants

Start Date

Sep 19, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Stage IV Oligometastatic Disease

Summary

TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a very precise form of radiation called stereotactic ablative radiotherapy (SABR) — which delivers high doses of radiation with pinpoint accuracy — can help control metastatic breast cancer that has spread to only a few places in the body (called oligometastatic disease). **You may be eligible if...** - You are 18 or older with breast cancer that has spread to 1–5 spots in up to two organs - Your cancer spread is confirmed by a PET-CT scan - Your cancer is stable or responding to your current treatment - Each cancer spot is no larger than 5 cm - You are reasonably active and have a life expectancy over 6 months **You may NOT be eligible if...** - You have more than 5 metastatic spots or involvement of more than 2 organs - Your primary breast tumor is not under control - You are too unwell to tolerate radiation treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSABR

Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.

Locations(19)

Cork University Hospital

Cork, Ireland

Bon Secours Cork In Partnership with UPMC Hillman Cancer Centre

Cork, Ireland

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

Dublin, Ireland

University Hospital Galway (UHG)

Galway, Ireland

Sheba Medical Center Institute of Oncology

Tel Aviv, Israel

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Humanitas Cancer Centre

Milan, Italy

Istituto Nationale Tumori (INT)

Milan, Italy

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital, Radiumhospitalet

Oslo, Norway

Universitetssykehuset Nord-Norge

Tromsø, Norway

St. Olavs Hospital

Trondheim, Norway

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Ryhov County Hospital

Jönköping, Region Jönköpings Län, Sweden

Skånes University Hospital

Malmö, Region Skåne, Sweden

Karolinska University Hospital

Stockholm, Region Stockholm, Sweden

Norrlands University Hospital

Umeå, Region Västerbotten, Sweden

Örebro University Hospital

Örebro, Region Örebro Län, Sweden

Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05377047

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