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

February 9, 2026 updated by: Istituto Clinico Humanitas
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BR
    • BS
      • Brescia, BS, Italy, 25123
    • Benevento
      • Benevento, Benevento, Italy, 82100
        • Not yet recruiting
        • Aorn San Pio
        • Contact:
    • Bergamo
      • Bergamo, Bergamo, Italy, 24125
    • CB
      • Campobasso, CB, Italy, 86100
    • Firenze
      • Florence, Firenze, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
    • Genova
      • Genova, Genova, Italy, 16132
    • MILANO
      • Milan, MILANO, Italy, 20133
      • Rozzano, MILANO, Italy, 20089
        • Recruiting
        • IRCCS Humanitas Research Humanitas
        • Contact:
        • Principal Investigator:
          • Ruggero Spoto, MD, Radiation Oncologist
    • Messina
      • Messina, Messina, Italy, 98124
        • Not yet recruiting
        • A.O.U. "G. Martino" - Università degli Studi di Messina
        • Contact:
    • Milan
      • Milan, Milan, Italy, 20132
        • Not yet recruiting
        • Irccs Ospedale San Raffaele
        • Contact:
    • Milano
      • Milan, Milano, Italy, 20141
        • Not yet recruiting
        • IEO
        • Contact:
    • NOVARA
      • Novara, NOVARA, Italy, 28100
    • Napoli
    • PD
      • Padua, PD, Italy, 35128
        • Not yet recruiting
        • Istituto Oncologico Veneto
        • Contact:
    • PI
    • PZ
      • Potenza, PZ, Italy, 85100
        • Not yet recruiting
        • Uo Radioterapia Aor San Carlo
        • Contact:
      • Rionero in Vulture, PZ, Italy, 85028
    • Palermo
      • Palermo, Palermo, Italy, 90127
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Not yet recruiting
        • IRCCS Centro di Riferimento Oncologico di Aviano
        • Contact:
    • RM
      • Roma, RM, Italy, 00135
      • Roma, RM, Italy, 00184
    • Roma
      • Roma, Roma, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Universitario, Campus-Biomedico
        • Contact:
      • Roma, Roma, Italy, 00133
      • Roma, Roma, Italy, 00189
    • TR
      • Terni, TR, Italy, 05100
        • Not yet recruiting
        • S.C. Radioterapia Oncologica - Azienda Ospedaliera Santa Maria Terni
        • Contact:
    • TRENTO
      • Trento, TRENTO, Italy, 38122
        • Not yet recruiting
        • Radioterapia Oncologica - Ospedale Sanata Chiara
        • Contact:
    • Taranto
      • Taranto, Taranto, Italy, 74100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with Oligometastatic or oligoprogressive metastatic breast cancer treated with SBRT

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TREATMENT SBRT
patients who have been treated with stereotactic radiotherapy to oligometastatic sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: from January 2010 to December 2023
years of survival without disease progression assessed by imaging
from January 2010 to December 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control
Time Frame: from January 2010 to December 2023
time between treatment and disease recurrence assessed by imaging
from January 2010 to December 2023
overall survival
Time Frame: From January 2010 to December 2023
the time from diagnosis or initiation of treatment until death from any cause
From January 2010 to December 2023
acute and late toxicity RT related
Time Frame: from January 2010 to December 2023
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)
from January 2010 to December 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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
  • D. 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.
  • N. N. Terao M, "Diagnosis of oligometastasis," Transl Cancer Res., 2020

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT/OSS - 001/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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