Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
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
This trial does not accept healthy volunteersQualifiers
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). Change due to toxicity allowed.
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
Design model
Parallel
Treatments tested in this trial
SABR
RadiationStereotactic Ablative Radiotherapy is delivered to all metastatic lesions.
Treatment groups
345 Participants
are divided into 2 treatment groupsGroup A: Experimental SABR armExperimental treatment 1 intervention
Group B: Control systemic therapy armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
Time from the date of randomisation to the date of disease-progression at any site or death from any cause.
Time frame
3 years after the last patient inclusionSecondary outcomes
1
Overall survival (OS)
Time from the date of randomisation to the date of death from any cause.
Time frame
3 years after the last patient inclusion2
Local Control Rate (LCR)
Time from the date of randomisation to the date of progress in previously treated metastases
Time frame
3 years after the last patient inclusion3
Safety analysis - acute toxicity
Reported according to CTCAE v.5.0
Time frame
From the first dose of SABR to 3 months after the last dose of SABR4
Safety analysis - late toxicity
Reported according to CTCAE v.5.0
Time frame
From the first dose of SABR to 3 years after the last dose of SABRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vastra Gotaland Region
Lead sponsor
Sahlgrenska University Hospital
Collaborator
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Region Örebro County
Collaborator
Skane University Hospital
Collaborator
Karolinska University Hospital
Collaborator
University Hospital, Umeå
Collaborator
Oslo University Hospital
Collaborator
St. Olavs Hospital
Collaborator
Haukeland University Hospital
Collaborator
University Hospital of North Norway
Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Collaborator
Cork University Hospital
Collaborator
St. James's Hospital, Ireland
Collaborator
Beaumont Hospital
Collaborator
Bon Secours Cork Cancer Centre
Collaborator
Galway University Hospitals
Collaborator
Institute of Oncology Ljubljana
Collaborator
Sheba Medical Center
Collaborator
Source ClinicalTrials.gov