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Taking people in IrelandPhase 3

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.

Key facts

Who runs it
Vastra Gotaland Region
Where
Cork, Dublin, and Galway, IrelandSee the 4 sitesAlso in 5 other countries, 15 sites
Trial code
Registry title
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Status
Recruiting
Phase
Phase 3
People taking part
345 people, planned
Started
19 Sept 2022
Expected to end
31 Dec 2030
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • SABR
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with breast cancer that has come back and spread to a small number of places (oligometastatic). It compares radiotherapy plus drug treatment with drug treatment alone as first treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Recurrent or newly found stage IV breast cancer with 1-5 metastases in at most two organs, confirmed by PET-CT. The main tumour or local recurrence must be controlled. ECOG/WHO 0-2 and life expectancy over 6 months.
Earlier treatment
People already on first-line drug treatment can join if repeated tumour checks show stable disease. No more than 1 line of drug treatment for the metastases because of progressing disease. Side effects from earlier adjuvant therapy must have recovered to grade 1.
Biomarker or test result
ER, PgR and HER2 status of the primary tumour or a metastasis should be known (preferred).

Main reasons for not taking part

  • Metastases in the brain
  • Fluid from cancer in the chest cavity or belly (malignant pleural effusion or ascites)
  • Metastasis involving more than 3 vertebrae or pressing on the spinal cord
  • Another cancer needing treatment, or another cancer in the last 5 years (some skin and cervical cancers excepted)
  • Pregnancy or breast-feeding

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • > 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

Where in Ireland

Also in 5 other countries, 15 sites

  • Bon Secours Cork In Partnership with UPMC Hillman Cancer CentreCork, IrelandContact: Karen Molan, MDTaking people
  • Cork University HospitalCork, IrelandContact: Ella O'Sullivan, MDTaking people
  • St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital Dublin, St James Hospital Dublin and Beaumont Hospital DublinDublin, IrelandContact: Vitor OlivieraTaking people
  • University Hospital Galway (UHG)Galway, IrelandContact: Laura NallyTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Experimental SABR armTreatment being tested

    Standard first line systemic therapy + SABR.

    Treatment: SABR

  • Control systemic therapy armNo study treatment, for comparison

    Standard first line systemic therapy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests focused radiation with standard drugs for breast cancer spread to few sitesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 September 2026