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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
TREATMENT SBRT
patients who have been treated with stereotactic radiotherapy to oligometastatic sites

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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