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Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

Study acronym: TAORMINA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Dec 31, 2025 → Dec 31, 2028
See other at-risk trials from Vastra Gotaland Region

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 12 words
    • Site details revised at 19 of 19 sites
    • Collaborators: details revised at 1 of 19 entries
    • Publications: details revised at 9 of 9 entries
  2. Primary completion pushed from Dec 31, 2025 to Dec 31, 2028v3 Show 6 more changesShow less
    • Phase changed: not applicable → Phase 3
    • Trial sites expanded: 1 → 19 locations
    • Study completion pushed from Dec 31, 2027 to Dec 31, 2030
    • Eligibility criteria shortened, about 6 words
    • Collaborators: 16 to 19
    • Publications: 8 to 9
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Start date changed from estimate of May 16, 2022 to Sep 19, 2022
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Secondary endpoints revised (6)
    • Study description expanded, about 75 words
    • Eligibility criteria expanded, about 3 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05377047
Lead Sponsor Vastra Gotaland Region
Collaborators: Sahlgrenska University Hospital, Azienda Ospedaliero-Universitaria Careggi, Region Örebro County, Skane University Hospital, Karolinska University Hospital, University Hospital, Umeå, Oslo University Hospital, St. Olavs Hospital, Haukeland University Hospital, University Hospital of North Norway, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Humanitas Research Hospital IRCCS, Rozzano-Milan, Cork University Hospital, St. James's Hospital, Ireland, Beaumont Hospital, Bon Secours Cork Cancer Centre, Galway University Hospitals, Institute of Oncology Ljubljana, Sheba Medical Center
Conditions
(from sponsor)		 Breast Cancer Stage IV, Oligometastatic Disease
Related terms Breast Neoplasms
Enrollment 345 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov