stereOtactic Body RadIothErapy for exTracranial oligomeTastAtic Breast Cancer: Multi Institutional Retrospective Database
ORIETTA
1 other identifier
observational
300
1 country
28
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
28 active sites
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 Start
First participant enrolled
February 25, 2025
CompletedFirst Submitted
Initial submission to the registry
February 2, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 11, 2026
February 1, 2026
1.8 years
February 2, 2026
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression free survival
years of survival without disease progression assessed by imaging
from January 2010 to December 2023
Secondary Outcomes (3)
Local Control
from January 2010 to December 2023
overall survival
From January 2010 to December 2023
acute and late toxicity RT related
from January 2010 to December 2023
Study Arms (1)
TREATMENT SBRT
patients who have been treated with stereotactic radiotherapy to oligometastatic sites
Eligibility Criteria
Patient with Oligometastatic or oligoprogressive metastatic breast cancer treated with SBRT
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Aorn San Pio
Benevento, Benevento, 82100, Italy
Humanitas Gavazzeni
Bergamo, Bergamo, 24125, Italy
Ospedale Perrino
Brindisi, BR, 72100, Italy
Spedali Civili
Brescia, BS, 25123, Italy
Responsible Research Hospital
Campobasso, CB, 86100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Firenze, 50134, Italy
Irccs Ospedale Policlinico San Martino
Genova, Genova, 16132, Italy
A.O.U. "G. Martino" - Università degli Studi di Messina
Messina, Messina, 98124, Italy
Fondazione I.R.C.C.S Istituto Nazionale Tumori di Milano
Milan, MILANO, 20133, Italy
IEO
Milan, Milano, 20141, Italy
IRCCS Humanitas Research Humanitas
Rozzano, MILANO, 20089, Italy
IRCCS Ospedale San Raffaele
Milan, Milan, 20132, Italy
INT IRCCS Fondazione G. Pascale
Naples, Napoli, 80131, Italy
Ospedale Maggiore della Carita
Novara, NOVARA, 28100, Italy
Civico Palermo
Palermo, Palermo, 90127, Italy
Istituto Oncologico Veneto
Padua, PD, 35128, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, PI, 56124, Italy
IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, Pordenone, 33081, Italy
Uo Radioterapia Aor San Carlo
Potenza, PZ, 85100, Italy
Irccs Crob
Rionero in Vulture, PZ, 85028, Italy
UOC Radioterapia Ospedale San Filippo Neri
Roma, RM, 00135, Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma, RM, 00184, Italy
Fondazione Policlinico Universitario, Campus-Biomedico
Roma, Roma, 00128, Italy
Fondazione PTV Policlinico Tor Vergata
Roma, Roma, 00133, Italy
Azienda Ospedaliera Sant'Andrea
Roma, Roma, 00189, Italy
S.C. Radioterapia Oncologica ASL Taranto
Taranto, Taranto, 74100, Italy
Radioterapia Oncologica - Ospedale Sanata Chiara
Trento, TRENTO, 38122, Italy
S.C. Radioterapia Oncologica - Azienda Ospedaliera Santa Maria Terni
Terni, TR, 05100, Italy
Related Publications (4)
T. G. S. L. C. M. V. M.-J. T. V. P. T. G. W. G. S. S. Annemiek van Ommen-Nijhof, "Survival and prognostic factors in oligometastatic breast cancer," the breast, 2022.
BACKGROUNDK. 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
BACKGROUNDD. A. P. Stephen Harrow, "Stereotactic Radiation for the Comprehensive Treatment of Oligometastases (SABR-COMET) - Extended Long-Term Outcomes," International Journal of Radiation Oncology, Biology, Physics, 2022.
BACKGROUNDN. N. Terao M, "Diagnosis of oligometastasis," Transl Cancer Res., 2020
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2026
First Posted
February 9, 2026
Study Start
February 25, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share