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Recruiting NCT07397585

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

— Observational Breast Cancer Oligometastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer, Oligometastasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • progression free survival [Time frame: from January 2010 to December 2023]
Secondary outcome measures (3)
  • Local Control [Time frame: from January 2010 to December 2023]
  • overall survival [Time frame: From January 2010 to December 2023]
  • acute and late toxicity RT related [Time frame: from January 2010 to December 2023]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 28 centers
  • Aorn San Pio — Benevento
  • Humanitas Gavazzeni — Bergamo
  • Ospedale Perrino — Brindisi
  • Spedali Civili — Brescia
  • Responsible Research Hospital — Campobasso
  • Azienda Ospedaliera Universitaria Careggi — Florence
  • Irccs Ospedale Policlinico San Martino — Genova
  • A.O.U. "G. Martino" - Università degli Studi di Messina — Messina
  • … and 20 more centers

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. PMID 36549169
  • 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
  • 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. PMID 35643253
  • Terao M, Niikura N. Diagnosis of oligometastasis. Transl Cancer Res. 2020 Aug;9(8):5032-5037. doi: 10.21037/tcr.2020.01.04. PMID 35117868

Identifiers

NCT: NCT07397585 · RT/OSS - 001/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗