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Breast Cancer Stage IVPhase 3TAORMINANCT05377047

Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

A Phase 3 study testing SABR in people with Breast Cancer Stage IV and Oligometastatic Disease, run by Vastra Gotaland Region at 19 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SABR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
345 participants
Where
19 sitesin 6 countries
Study dates
19 Sep 2022to 31 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 24Show fewer
  • 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 join

  • > 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.
  • Unable to undergo imaging by either CT scan or MRI.
  • 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.
  • Pregnancy or breast-feeding.
  • Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).

Trial locations and contacts

19 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Katarzyna Kulbacka-Ortiz, CTO contact

+46721470685

katarzyna.kulbacka-ortiz@vgregion.se

Annika Baan contact

+46700906097

annika.baan@vgregion.se

19 sites in 6 countries

Sweden6 sites, 6 recruiting

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götalandsregionen, 41345

    Katarzyna Kulbacka, Head CTO, katarzyna.kulbacka-ortiz@vgregion.se

    Mitra Sharifi Jahanfard, Study nurse, +46-31-3426791, mitra.sharifi-jahanfard@vgregion.se

    Recruiting

  • Ryhov County Hospital

    Jönköping, Region Jönköpings Län, 551 85

    Therese Karlsson, Study nurse, +46 10-242 59 62, therese.i.karlsson@rjl.se

    Maria Ekholm, MD, PhD

    Recruiting

  • Skånes University Hospital

    Malmö, Region Skåne

    Charlotta Wollheim, Study nurse, +46 40 337461, charlotta.wollheim@skane.se

    Muhammad Kadum, MD

    Recruiting

  • Örebro University Hospital

    Örebro, Region Örebro Län, SE-701 85

    Emma Nordh, Study nurse, +46 19 602 27 19, emma.nordh@regionorebrolan.se

    Jenny Larsson, Study nurse, +46-31-3426791, jenny.larsson4@regionorebrolan.se

    Recruiting

  • Karolinska University Hospital

    Stockholm, Region Stockholm, 17176

    Karin Hedgren, Study nurse, +46-8-123 71746, karin.hedgren@regionstockholm.se

    Caroline Boman, MD

    Recruiting

  • Norrlands University Hospital

    Umeå, Region Västerbotten, 901 85

    Dmitry Domkin, Study nurse, +46 90-785 35 95, dmitry.domkin@regionvasterbotten.se

    Jeanette Johansson, Study nurse, +46-90-785 06 89, jeanette.johansson@regionvasterbotten.se

    Recruiting

Other trials in Sweden

Ireland4 sites, 4 recruiting

  • Cork University Hospital

    Cork, T12 DC4A

    Ella O'Sullivan, MD, +353 (0) 21 4922000, ella.osullivan@hse.ie

    Aisling Barry, Prof.

    Recruiting

  • Bon Secours Cork In Partnership with UPMC Hillman Cancer Centre

    Cork, T12 DV56

    Karen Molan, MD, +353 (0)21-486 1100, molank@upmc.ie

    Kathy Rock, MD

    Recruiting

  • St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital Dublin, St James Hospital Dublin and Beaumont Hospital Dublin

    Dublin

    Vitor Oliviera, +353 (0) -1-420 6900, Vitor.Oliveira@slh.ie

    Frances Duane, Prof.

    Recruiting

  • University Hospital Galway (UHG)

    Galway, H91 YR71

    Laura Nally, +353 91 54 2785, laura.nally@hse.ie

    Ronan McDermott, MD

    Recruiting

Other trials in Ireland

Norway4 sites, 4 recruiting

  • Haukeland University Hospital

    Bergen, 5021

    Vidhi Shukla, MD, +47 55 97 50 00, vidi.shukla@helse-bergen.no

    Vidhi Shukla, MD

    Recruiting

  • Oslo University Hospital, Radiumhospitalet

    Oslo, 0424

    Veronica Feilum, +47-942244, uxfeve@ous-hf.no

    Maria Elena Rodriguez Aguillar, maerod@ous-hf.no

    Recruiting

  • Universitetssykehuset Nord-Norge

    Tromsø, 9019

    Kristin Iren Jensen, + 47 77 66 92 12, Kristin.Iren.Jensen@unn.no

    Maria Therese Danielsen, maria.theres.danielsen@unn.no

    Recruiting

  • St. Olavs Hospital

    Trondheim, 7006

    Kjerstin Olaussen, +47-72825782, Kjerstin.Olaussen@stolav.no

    Britt Torun Fjær Nydal, Britt.Torunn.Fjer.Nydal@stolav.no

    Recruiting

Other trials in Norway

Italy3 sites, 3 recruiting

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 3 50134

    Michela Carracino, +390552751828, carracinom@aou-careggi.toscana.it

    Icro Meattini, Prof.

    Recruiting

  • Humanitas Cancer Centre

    Milan

    Marta Scorsetti, MD, PhD, +39 02 8224 8524, marta.scorsetti@hunimed.eu

    Marta Scorsetti, Prof.

    Recruiting

  • Istituto Nationale Tumori (INT)

    Milan

    Maria Carmen De Santis, MD, +39-0223903280, mariacarmen.desantis@istitutotumori.mi.it

    Maria Carmen De Santis, Prof.

    Recruiting

Other trials in Italy

Israel1 site, 1 recruiting

  • Sheba Medical Center Institute of Oncology

    Tel Aviv, 5265601

    Aliza Ackerstein, +972-3-5302542, aliza.ackerstein@sheba.health.gov.il

    Chen Gross, Chen.Gross@sheba.health.gov.il

    Recruiting

Other trials in Israel

Slovenia1 site, 1 recruiting

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

    Minka Macanovic, +386 (0)1 58 79 550, mmacanovic@onko-i.si

    Erika Primc, eprimc@onko-i.si

    Recruiting

Other trials in Slovenia

About this study

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

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 the detailed 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.

Patients with 1-5 metastases in 1-2 organs (confirmed by PET-CT) with any breast cancer subtype can be enrolled. All metastases must be available for SABR.

The primary aim is to investigate if the addition of SABR to the oligometastatic sites in addition to the standard first-line treatment can improve progression-free survival (PFS).

Secondary aims are to compare overall survival (OS), response rate and time to development of new lesions, acute and late toxicity. quality of life, time to start of chemotherapy (luminal patients).

Exploratory analyses:

Circulating tumour DNA as an early sign of disease progression. Immun panel for determination of the effect of SABR on patients´ immune response.

To investigate the survival for each BC subtype (Luminal, HER2+ and TNBC). To investigate survival in patients with de novo OMBC and recurrent OMBC respectively.

Stratifications are based on subtype (luminal, HER2-positive vs TNBC) and type of OMBC (de novo vs. recurrent) without formal sample size calculation for the stratification factor (exploratory analysis).

Patients with de novo metastatic OMBC that is planned for neoadjuvant treatment are recommended to complete treatment followed by standard surgery and radiotherapy or SABR towards the primary tumour lesion(s).

Being tested
SABR
Keywords
SBRT, SABR, OMBC
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SABRRadiation

    Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.

Study groups in NCT05377047
Study groupRoleWhat they receive
Experimental SABR armExperimentalStandard first line systemic therapy + SABR.
Receives: Radiation: SABR
Control systemic therapy armNo interventionStandard first line systemic therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years after the last patient inclusion

Secondary outcomes (6)

  1. Overall survival (OS)

    Time from the date of randomisation to the date of death from any cause.

    Measured: 3 years after the last patient inclusion

  2. Local Control Rate (LCR)

    Time from the date of randomisation to the date of progress in previously treated metastases

    Measured: 3 years after the last patient inclusion

  3. Safety analysis - acute toxicity

    Reported according to CTCAE v.5.0

    Measured: From the first dose of SABR to 3 months after the last dose of SABR

  4. Safety analysis - late toxicity

    Reported according to CTCAE v.5.0

    Measured: From the first dose of SABR to 3 years after the last dose of SABR

  5. Health-related quality of life Cancer-30

    European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaires Cancer-30 (EORTC-QLQ C30)

    Measured: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.

  6. Health-related quality of life Breast-23

    European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Breast-23 (EORTC-QLQ B23)

    Measured: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start19 Sep 2022
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomisation 2:1 (systemic treatment + SABR vs systemic treatment)
Masking
None (open label)
Enrolment
345 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05377047
Sponsor's protocol ID
SABO 21-01
Acronym
TAORMINA
Status last verified
Sep 2026
First submitted
11 Apr 2022
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chalkidou A, Macmillan T, Grzeda MT, Peacock J, Summers J, Eddy S, Coker B, Patrick H, Powell H, Berry L, Webster G, Ostler P, Dickinson PD, Hatton MQ, Henry A, Keevil S, Hawkins MA, Slevin N, van As N. Stereotactic ablative body radiotherapy in patients with oligometastatic cancers: a prospective, registry-based, single-arm, observational, evaluation study. Lancet Oncol. 2021 Jan;22(1):98-106. doi: 10.1016/S1470-2045(20)30537-4.

    PubMed 33387498

  • Milano MT, Zhang H, Metcalfe SK, Muhs AG, Okunieff P. Oligometastatic breast cancer treated with curative-intent stereotactic body radiation therapy. Breast Cancer Res Treat. 2009 Jun;115(3):601-8. doi: 10.1007/s10549-008-0157-4. Epub 2008 Aug 22.

    PubMed 18719992

  • Milano MT, Katz AW, Zhang H, Okunieff P. Oligometastases treated with stereotactic body radiotherapy: long-term follow-up of prospective study. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):878-86. doi: 10.1016/j.ijrobp.2011.08.036. Epub 2011 Dec 13.

    PubMed 22172903

  • Scorsetti M, Franceschini D, De Rose F, Comito T, Villa E, Iftode C, Navarria P, D'Agostino GR, Masci G, Torrisi R, Testori A, Tinterri C, Santoro A. Stereotactic body radiation therapy: A promising chance for oligometastatic breast cancer. Breast. 2016 Apr;26:11-7. doi: 10.1016/j.breast.2015.12.002. Epub 2016 Jan 3.

    PubMed 27017237

  • Milano MT, Katz AW, Zhang H, Huggins CF, Aujla KS, Okunieff P. Oligometastatic breast cancer treated with hypofractionated stereotactic radiotherapy: Some patients survive longer than a decade. Radiother Oncol. 2019 Feb;131:45-51. doi: 10.1016/j.radonc.2018.11.022. Epub 2018 Dec 28.

    PubMed 30773186

  • Trovo M, Furlan C, Polesel J, Fiorica F, Arcangeli S, Giaj-Levra N, Alongi F, Del Conte A, Militello L, Muraro E, Martorelli D, Spazzapan S, Berretta M. Radical radiation therapy for oligometastatic breast cancer: Results of a prospective phase II trial. Radiother Oncol. 2018 Jan;126(1):177-180. doi: 10.1016/j.radonc.2017.08.032. Epub 2017 Sep 21.

    PubMed 28943046

  • David S, Tan J, Savas P, Bressel M, Kelly D, Foroudi F, Loi S, Siva S. Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. Breast. 2020 Feb;49:55-62. doi: 10.1016/j.breast.2019.10.016. Epub 2019 Nov 6.

    PubMed 31734589

  • Li MP, Kelly D, Tan J, Siva S, Kron T, David S. Single-fraction stereotactic ablative body radiotherapy for sternal metastases in oligometastatic breast cancer: Technique and single institution experience. J Med Imaging Radiat Oncol. 2020 Aug;64(4):580-585. doi: 10.1111/1754-9485.13075. Epub 2020 Jun 25.

    PubMed 32588550

  • Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.

    PubMed 32484754

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SABR in people with Breast Cancer Stage IV and Oligometastatic Disease, run by Vastra Gotaland Region at 19 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Sweden, Ireland, Norway, Italy, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katarzyna Kulbacka-Ortiz, CTO (+46721470685, katarzyna.kulbacka-ortiz@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 3 years after the last patient inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05377047, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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