Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
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 criteria
Qualifiers
Histologically or cytological confirmed recurrent OMBC.
Age ≥18 years old.
OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.
Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.
Disqualifiers
> 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).
Oligometastases in brain.
Malignant pleural effusion or ascites.
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.
Trial design
Treatments tested in this trial
- SABR
Treatment groups
345 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vastra Gotaland Region
Lead sponsor
Sahlgrenska University Hospital
Collaborator
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Region Örebro County
Collaborator
Skane University Hospital
Collaborator
Uppsala University Hospital
Collaborator
Karolinska University Hospital
Collaborator
University Hospital, Umeå
Collaborator
Sundsvall Hospital
Collaborator
Karlstad Central Hospital
Collaborator
Gävle Hospital
Collaborator
Centrallasarettet Västerås
Collaborator
Oslo University Hospital
Collaborator
St. Olavs Hospital
Collaborator
Haukeland University Hospital
Collaborator
University of Stavanger
Collaborator
University Hospital of North Norway
Collaborator
Source ClinicalTrials.gov