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Breast CancerORIETTANCT07397585

stereOtactic Body RadIothErapy for exTracranial oligomeTastAtic Breast Cancer: Multi Institutional Retrospective Database

An observational study of Breast Cancer and Oligometastasis, run by Istituto Clinico Humanitas at 28 sites in Italy.

Recruiting

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

Sites and contacts
Official record

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Trial summary

Oligometastatic breast cancer is a condition in which breast cancer has spread to a small number of other parts of the body. Patients with this type of disease may live longer than those with more widespread metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Oligometastasis
How many people
300 participants
Where
28 sitesItaly
Study dates
25 Feb 2025to 31 Dec 2026
Phase
Observational

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

Study population: Patient with Oligometastatic or oligoprogressive metastatic breast cancer treated with SBRT

Who may be able to join

  • Patients ≥18 years
  • Histological diagnosis of breast cancer
  • Oligometastatic or oligoprogressive metastatic breast cancer
  • SBRT delivered to a minimum dose of 50Gy EQD2 (αβ 10 Gy),in a maximum of 12 fractions as per Oligocare definition
  • Ability to provide written informed consent

Who cannot join

None listed.

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ruggero Spoto, MD, Radiation oncologist contact

+39 0282248508

ruggero.spoto@cancercenter.humanitas.it

Laura Bonavita, Master Degree contact

+39 0282247026

laura.bonavita@humanitas.it

28 sites in 1 country

Italy28 sites, 28 recruiting

  • IRCCS Centro di Riferimento Oncologico di Aviano

    Aviano, Pordenone, 33081

    Angela Caroli, MD, Radiation Oncologist, angela.caroli@cro.it

    Not yet recruiting

  • Aorn San Pio

    Benevento, Benevento, 82100

    Angela Argenone, MD, Radiation Oncologist, argenone@libero.it

    Not yet recruiting

  • Humanitas Gavazzeni

    Bergamo, Bergamo, 24125

    Rosario Mazzola, MD, Radiation Oncologist, rosario.mazzola@hunimed.eu

    Recruiting

  • Spedali Civili

    Brescia, BS, 25123

    Sara Pedretti, MD, radiation oncologist, sara.pedretti1984@gmail.com

    Recruiting

  • Ospedale Perrino

    Brindisi, BR, 72100

    Alessandra Castelluccia, MD, Radiation oncologist, alessandra.castelluccia@gmail.com

    Not yet recruiting

  • Responsible Research Hospital

    Campobasso, CB, 86100

    Gabriella Macchia, MD, radiation oncologist, Macchiagabriella@gmail.com

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Firenze, 50134

    Icro Meattini, MD, Radiation Oncologist, icro.meattini@unifi.it

    Not yet recruiting

  • Irccs Ospedale Policlinico San Martino

    Genova, Genova, 16132

    Alessandra Fozza, MD, radiation oncologist, alessandra.fozza@hsanmartino.it

    Not yet recruiting

  • A.O.U. "G. Martino" - Università degli Studi di Messina

    Messina, Messina, 98124

    Antonio Pontoriero, MD, radiation oncologist, apontoriero@unime.it

    Not yet recruiting

  • Fondazione I.R.C.C.S Istituto Nazionale Tumori di Milano

    Milan, MILANO, 20133

    Maria Carmen De Santis, MD, Radiation Oncologist, mariacarmen.desantis@istitutotumori.mi.it

    Recruiting

  • IEO

    Milan, Milano, 20141

    Gaia Piperno, MD, Radiation Oncologist, gaia.piperno@ieo.it

    Not yet recruiting

  • IRCCS Ospedale San Raffaele

    Milan, Milan, 20132

    Roberta Tumminieri, MD, Radiation Oncologist, tummineri.roberta@hsr.it

    Not yet recruiting

  • INT IRCCS Fondazione G. Pascale

    Naples, Napoli, 80131

    Sara Falivene, MD, Radiation Oncologist, sara.falivene@istitutotumori.na.it

    Recruiting

  • Ospedale Maggiore della Carita

    Novara, NOVARA, 28100

    Pierfrancesco Franco, MD, radiation oncologist, pierfrancesco.franco@uniupo.it

    Recruiting

  • Istituto Oncologico Veneto

    Padova, PD, 35128

    Sara Talomo, MD, Radiation oncologist, sara.talomo@iov.veneto.it

    Not yet recruiting

  • Civico Palermo

    Palermo, Palermo, 90127

    Antonio Spera, MD, Radiation oncologist, antonio.spera@arnascivico.it

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, PI, 56124

    Martina Cantarella, MD, Radiation oncologist, martina.cantarella@ao-pisa.toscana.it

    Not yet recruiting

  • Uo Radioterapia Aor San Carlo

    Potenza, PZ, 85100

    Giuseppe Vittorino Giovinazzo, g.v.giovinazzo@gmail.com

    Not yet recruiting

  • Irccs Crob

    Rionero in Vulture, PZ, 85028

    Grazia Lazzari, MD, radiation oncologist, grazia.lazzari@crob.it

    Recruiting

  • UOC Radioterapia Ospedale San Filippo Neri

    Roma, RM, 00135

    Antonella Ciabattoni, MD, radiation oncologist, antonella.ciabattoni@aslroma1.it

    Not yet recruiting

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma, RM, 00184

    Angela Damiana Andrulli, adandrulli@hsangiovanni.roma.it

    Not yet recruiting

  • Fondazione Policlinico Universitario, Campus-Biomedico

    Roma, Roma, 00128

    Edy Ippolito, MD, Radiation Oncologist, e.ippolito@unicampus.it

    Recruiting

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Roma, 00133

    D'Angelillo Rolando Maria, rolandomaria.dangelillo@ptvonline.it

    Not yet recruiting

  • Azienda Ospedaliera Sant'Andrea

    Roma, Roma, 00189

    Barbara Campanella, MD, radiation oncologist, bcampanella@ospedalesantandrea.it

    Not yet recruiting

  • IRCCS Humanitas Research Humanitas

    Rozzano, MILANO, 20089

    Ruggero Spoto, MD, Radiation oncologist, +39 0282248508, ruggero.spoto@cancercenter.humanitas.it

    Ruggero Spoto, MD, Radiation Oncologist

    Recruiting

  • S.C. Radioterapia Oncologica ASL Taranto

    Taranto, Taranto, 74100

    Annarita Marsella, MD, Radiation Oncologist, annarita.marsella@asl.taranto.it

    Not yet recruiting

  • S.C. Radioterapia Oncologica - Azienda Ospedaliera Santa Maria Terni

    Terni, TR, 05100

    Fabio Arcidiacono, MD, Radiation Oncologist, f.arcidiacono@aospterni.it

    Not yet recruiting

  • Radioterapia Oncologica - Ospedale Sanata Chiara

    Trento, TRENTO, 38122

    Fiorenza Derose, MD, Radiation oncologist, fiorenza.derose@apss.tn.it

    Not yet recruiting

Other trials in Italy

About this study

Oligometastatic breast cancer is a condition in which breast cancer has spread to a small number of other parts of the body. Patients with this type of disease may live longer than those with more widespread metastases. In addition to standard treatments that act on the whole body, such as chemotherapy or hormonal therapy, these patients might also benefit from local treatments that directly target the cancer spots. One of these local treatments is stereotactic body radiotherapy (SBRT), a non-invasive radiation treatment that delivers high doses of radiation in a few sessions. In the past, most of the evidence about the benefit of local treatments came from surgery. More recently, there has been growing interest in SBRT because it does not require surgery. However, the results of studies so far have not been consistent.The goal of this multicenter retrospective study is to better understand whether SBRT can improve disease control and survival in patients with breast cancer that has spread to a limited number of sites outside the brain.

Keywords
breast cancer, oligometastasis, radiotherapy, SBRT
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT07397585
Study groupRoleWhat they receive
TREATMENT SBRTpatients who have been treated with stereotactic radiotherapy to oligometastatic sites

What is being measured

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

  1. progression free survival

    years of survival without disease progression assessed by imaging

    Measured: from January 2010 to December 2023

Secondary outcomes (3)

  1. Local Control

    time between treatment and disease recurrence assessed by imaging

    Measured: from January 2010 to December 2023

  2. overall survival

    the time from diagnosis or initiation of treatment until death from any cause

    Measured: From January 2010 to December 2023

  3. acute and late toxicity RT related

    Evaluation of toxicities related to radiotherapy treatment using the scale CTCAE (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)

    Measured: from January 2010 to December 2023

Timeline

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

  1. First posted9 Feb 2026
  2. Study start25 Feb 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397585
Sponsor's protocol ID
RT/OSS - 001/2025
Acronym
ORIETTA
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Ommen-Nijhof A, Steenbruggen TG, Capel L, Vergouwen M, Vrancken Peeters MT, Wiersma TG, Sonke GS. Survival and prognostic factors in oligometastatic breast cancer. Breast. 2023 Feb;67:14-20. doi: 10.1016/j.breast.2022.12.007. Epub 2022 Dec 14.

    PubMed 36549169

  • K. A. W. W. A. W. V. F. B. J. K. Steven J. Chmura, "NRG-BR002: A phase IIR/III trial of standard of care systemic therapy with or without stereotactic body radiotherapy (SBRT) and/or surgical resection (SR) for newly oligometastatic breast cancer," ASCO, 2022

  • Harrow S, Palma DA, Olson R, 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, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Radiation for the Comprehensive Treatment of Oligometastases (SABR-COMET): Extended Long-Term Outcomes. Int J Radiat Oncol Biol Phys. 2022 Nov 15;114(4):611-616. doi: 10.1016/j.ijrobp.2022.05.004. Epub 2022 May 26.

    PubMed 35643253

  • Terao M, Niikura N. Diagnosis of oligometastasis. Transl Cancer Res. 2020 Aug;9(8):5032-5037. doi: 10.21037/tcr.2020.01.04.

    PubMed 35117868

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