Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07397585
Acronym
ORIETTA
Enrollment
300
Registered
2026-02-09
Start date
2025-02-25
Completion date
2026-12-31
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Oligometastasis

Keywords

breast cancer, oligometastasis, radiotherapy, SBRT

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.

Interventions

None listed

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
progression free survivalfrom January 2010 to December 2023years of survival without disease progression assessed by imaging

Secondary

MeasureTime frameDescription
Local Controlfrom January 2010 to December 2023time between treatment and disease recurrence assessed by imaging
overall survivalFrom January 2010 to December 2023the time from diagnosis or initiation of treatment until death from any cause
acute and late toxicity RT relatedfrom January 2010 to December 2023Evaluation 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)

Countries

Italy

Contacts

CONTACTRuggero Spoto, MD, Radiation oncologist
ruggero.spoto@cancercenter.humanitas.it+39 0282248508
CONTACTLaura Bonavita, Master Degree
laura.bonavita@humanitas.it+39 0282247026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026