Tests focused radiation with standard drugs for breast cancer spread to few sites
Tests focused radiation plus standard drugs in adults with limited spread of breast cancer.
Plain-language title generated from the registry record
Registry title: Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Key facts
- Where
- Gothenburg, Jönköping, Malmö, Örebro, Stockholm, and Umeå, SwedenSee the 6 sites
- Phase
- Phase 3
Where in Sweden
- Sahlgrenska University HospitalGothenburg, SwedenTaking people
- Ryhov County HospitalJönköping, SwedenTaking people
- Skånes University HospitalMalmö, SwedenTaking people
- Örebro University HospitalÖrebro, SwedenTaking people
- Karolinska University HospitalStockholm, SwedenTaking people
- Norrlands University HospitalUmeå, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vastra Gotaland Region
- Trial code
- NCT05377047
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment; Patients with local recurrence and OMBC must have a controlled local recurrence; ECOG/WHO 0-2; Life expectancy > 6 months; Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred); Symptomatic bone metastases are allowed if ablative therapy can be delivered; Adequate organ function for the planned treatment according to local guide-lines; 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; For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of > 60mL/min; 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; Negative pregnancy test within 14 days prior to start of treatment*; If childbearing potential, willing to use an effective form of contraception*; 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; Signed informed consent and willingness to follow the trial procedures.
Exclusion: > 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; Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ); Malignant pleural effusion or ascites; 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; Oligometastases in brain; 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; Unable to undergo imaging by either CT scan or MRI; Pregnancy or breast-feeding.