NCT05377047

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P50-P75 for phase_3

Timeline
52mo left

Started Sep 2022

Longer than P75 for phase_3

Geographic Reach
6 countries

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Sep 2022Dec 2030

First Submitted

Initial submission to the registry

April 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 19, 2022

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

6.3 years

First QC Date

April 11, 2022

Last Update Submit

September 16, 2026

Conditions

Breast Cancer Stage IVOligometastatic Disease

Keywords

SBRTSABROMBC

Outcome Measures

Primary Outcomes (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.

    3 years after the last patient inclusion

Secondary Outcomes (6)

  • Overall survival (OS)

    3 years after the last patient inclusion

  • Local Control Rate (LCR)

    3 years after the last patient inclusion

  • Safety analysis - acute toxicity

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

  • Safety analysis - late toxicity

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

  • Health-related quality of life Cancer-30

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

  • +1 more secondary outcomes

Study Arms (2)

Experimental SABR arm

EXPERIMENTAL

Standard first line systemic therapy + SABR.

Radiation: SABR

Control systemic therapy arm

NO INTERVENTION

Standard first line systemic therapy.

Interventions

SABRRADIATION

Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.

Experimental SABR arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +9 more criteria

You may not qualify if:

  • \> 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Cork University Hospital

Cork, T12 DC4A, Ireland

RECRUITING

Bon Secours Cork In Partnership with UPMC Hillman Cancer Centre

Cork, T12 DV56, Ireland

RECRUITING

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

Dublin, Ireland

RECRUITING

University Hospital Galway (UHG)

Galway, H91 YR71, Ireland

RECRUITING

Sheba Medical Center Institute of Oncology

Tel Aviv, 5265601, Israel

RECRUITING

Azienda Ospedaliero - Universitaria Careggi

Florence, 3 50134, Italy

RECRUITING

Humanitas Cancer Centre

Milan, Italy

RECRUITING

Istituto Nationale Tumori (INT)

Milan, Italy

RECRUITING

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Oslo University Hospital, Radiumhospitalet

Oslo, 0424, Norway

RECRUITING

Universitetssykehuset Nord-Norge

Tromsø, 9019, Norway

RECRUITING

St. Olavs Hospital

Trondheim, 7006, Norway

RECRUITING

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Ryhov County Hospital

Jönköping, Region Jönköpings Län, 551 85, Sweden

RECRUITING

Skånes University Hospital

Malmö, Region Skåne, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Region Stockholm, 17176, Sweden

RECRUITING

Norrlands University Hospital

Umeå, Region Västerbotten, 901 85, Sweden

RECRUITING

Örebro University Hospital

Örebro, Region Örebro Län, SE-701 85, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, 41345, Sweden

RECRUITING

Related Publications (9)

  • 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.

    PMID: 33387498BACKGROUND

  • 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.

    PMID: 18719992BACKGROUND

  • 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.

    PMID: 22172903BACKGROUND

  • 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.

    PMID: 27017237BACKGROUND

  • 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.

    PMID: 30773186BACKGROUND

  • 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.

    PMID: 28943046BACKGROUND

  • 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.

    PMID: 31734589BACKGROUND

  • 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.

    PMID: 32588550BACKGROUND

  • 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.

    PMID: 32484754BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Barbro K Linderholm, MD, PhD

    Sahlgrenska University Hospital, Gothenburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Kulbacka-Ortiz, CTO

CONTACT

+46721470685katarzyna.kulbacka-ortiz@vgregion.se

Annika Baan

CONTACT

+46700906097annika.baan@vgregion.se

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomisation 2:1 (systemic treatment + SABR vs systemic treatment)
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 17, 2022

Study Start

September 19, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(6)IT(3)SL(1)IE(4)NO(4)IL(1)