RECRUITING
Phase 3
ClinicalTrials.gov
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Sponsor: Vastra Gotaland Region • ClinicalTrials.gov ID: NCT05377047
Registry updated: 2026-09-21
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Check Eligibility →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.
Interventions
-
SABR
(Radiation)
Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.
Eligibility criteria
Inclusion Criteria:
1. Histologically or cytological confirmed recurrent OMBC.
2. Age ≥18 years old.
3. OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.
4. Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.
5. Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.
6. Patients with local recurrence and OMBC must have a controlled local recurrence.
7. ECOG/WHO 0-2.
8. Life expectancy \> 6 months.
9. Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).
10. Symptomatic bone metastases are allowed if ablative therapy can be delivered.
11. Adequate organ function for the planned treatment according to local guide-lines.
12. 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.
13. For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of \> 60mL/min.
14. 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.
15. Negative pregnancy test within 14 days prior to start of treatment\*.
16. If childbearing potential, willing to use an effective form of contraception\*.
17. 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.
18. Signed informed consent and willingness to follow the trial procedures.
Exclusion Criteria:
1. \> 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.
2. Oligometastases in brain.
3. Malignant pleural effusion or ascites.
4. 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.
5. Unable to undergo imaging by either CT scan or MRI.
6. 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.
7. Pregnancy or breast-feeding.
8. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
Conditions
Breast Cancer Stage IV
Oligometastatic Disease
Locations
- 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
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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