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.
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
28 sites in 1 country
Italy28 sites, 28 recruiting
- Not yet 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
- 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
- Not yet recruiting
Ospedale Perrino
Brindisi, BR, 72100
Alessandra Castelluccia, MD, Radiation oncologist, alessandra.castelluccia@gmail.com
- Recruiting
Responsible Research Hospital
Campobasso, CB, 86100
Gabriella Macchia, MD, radiation oncologist, Macchiagabriella@gmail.com
- Not yet 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
- 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
- Not yet 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
- 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
- Not yet 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
- Recruiting
Irccs Crob
Rionero in Vulture, PZ, 85028
Grazia Lazzari, MD, radiation oncologist, grazia.lazzari@crob.it
- Not yet 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
- Recruiting
Fondazione Policlinico Universitario, Campus-Biomedico
Roma, Roma, 00128
Edy Ippolito, MD, Radiation Oncologist, e.ippolito@unicampus.it
- Not yet 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
- 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
- Not yet 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
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.
- Conditions
- Breast Cancer, Oligometastasis
- 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 group | Role | What they receive |
|---|---|---|
| TREATMENT SBRT | patients 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.
progression free survival
years of survival without disease progression assessed by imaging
Measured: from January 2010 to December 2023
Secondary outcomes (3)
Local Control
time between treatment and disease recurrence assessed by imaging
Measured: from January 2010 to December 2023
overall survival
the time from diagnosis or initiation of treatment until death from any cause
Measured: From January 2010 to December 2023
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.
- First posted9 Feb 2026
- Study start25 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 36549169K. 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 35643253Terao M, Niikura N. Diagnosis of oligometastasis. Transl Cancer Res. 2020 Aug;9(8):5032-5037. doi: 10.21037/tcr.2020.01.04.
PubMed 35117868