Clinical trial Recruiting at 9 sites Observational Ages 18 and up

Stereotactic body radiotherapy for extracranial oligometastatic breast cancer

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

Run by Istituto Clinico Humanitas · NCT07397585 · Data updated 2026-11-12

This project sees if stereotactic body radiotherapy (SBRT) helps control cancer and extend survival in adults with extracranial oligometastatic breast cancer.

More Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorIstituto Clinico Humanitas
Academic / other
Drugs / interventionschemotherapy, radiation
Locations28 sites (Benevento, Benevento and 27 other locations)
StatusRecruiting
StartedFebruary 25, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 11, 2026
Trial IDNCT07397585 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with histologically confirmed breast cancer and extracranial oligometastatic or oligoprogressive disease who received SBRT at an equivalent dose of ≥50 Gy EQD2 in ≤12 fractions are ideal candidates for inclusion.

Probably not a fit

Patients with widespread, non-oligometastatic disease, intracranial-only metastases, poor performance status, or those who did not receive SBRT at the specified dose/fractionation are unlikely to benefit from the findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter retrospective database collects clinical and treatment data from adults with extracranial oligometastatic or oligoprogressive breast cancer who received SBRT at participating Italian centers. Included cases must have histologically confirmed breast cancer and SBRT delivered at a minimum equivalent dose of 50 Gy EQD2 in no more than 12 fractions. Investigators will analyze outcomes such as local control, progression-free survival, overall survival, and treatment-related toxicity across institutions. The project aims to clarify whether SBRT provides consistent disease control or survival advantages given prior heterogeneous results.

Why it matters

Potential benefit: If successful, the findings could show whether SBRT offers better local control or longer survival for patients with limited breast cancer metastases, helping inform treatment choices.

How similar studies have gone: Previous surgical series and some SBRT reports have suggested benefit for oligometastatic cancer, but SBRT results specifically for breast cancer have been inconsistent and remain unproven.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Humanitas Gavazzeni
    Bergamo, Bergamo, Italy
    Recruiting
  • Spedali Civili
    Brescia, Bs, Italy
    Recruiting
  • Responsible Research Hospital
    Campobasso, Cb, Italy
    Recruiting
  • Fondazione I.R.C.C.S Istituto Nazionale Tumori di Milano
    Milan, Milano, Italy
    Recruiting
  • IRCCS Humanitas Research Humanitas
    Rozzano, Milano, Italy
    Recruiting
  • INT IRCCS Fondazione G. Pascale
    Naples, Napoli, Italy
    Recruiting
Show 22 more locations
  • Ospedale Maggiore della Carita
    Novara, Novara, Italy
    Recruiting
  • Irccs Crob
    Rionero in Vulture, Pz, Italy
    Recruiting
  • Fondazione Policlinico Universitario, Campus-Biomedico
    Roma, Roma, Italy
    Recruiting
  • Aorn San Pio
    Benevento, Benevento, Italy
    Not yet recruiting
  • Ospedale Perrino
    Brindisi, Br, Italy
    Not yet recruiting
  • Azienda Ospedaliera Universitaria Careggi
    Florence, Firenze, Italy
    Not yet recruiting
  • Irccs Ospedale Policlinico San Martino
    Genova, Genova, Italy
    Not yet recruiting
  • A.O.U. "G. Martino" - Università degli Studi di Messina
    Messina, Messina, Italy
    Not yet recruiting
  • Ieo
    Milan, Milano, Italy
    Not yet recruiting
  • IRCCS Ospedale San Raffaele
    Milan, Milan, Italy
    Not yet recruiting
  • Civico Palermo
    Palermo, Palermo, Italy
    Not yet recruiting
  • Istituto Oncologico Veneto
    Padova, Pd, Italy
    Not yet recruiting
  • Azienda Ospedaliera Universitaria Pisana
    Pisa, Pi, Italy
    Not yet recruiting
  • IRCCS Centro di Riferimento Oncologico di Aviano
    Aviano, Pordenone, Italy
    Not yet recruiting
  • Uo Radioterapia Aor San Carlo
    Potenza, Pz, Italy
    Not yet recruiting
  • UOC Radioterapia Ospedale San Filippo Neri
    Roma, Rm, Italy
    Not yet recruiting
  • Azienda Ospedaliera San Giovanni Addolorata
    Roma, Rm, Italy
    Not yet recruiting
  • Fondazione PTV Policlinico Tor Vergata
    Roma, Roma, Italy
    Not yet recruiting
  • Azienda Ospedaliera Sant'Andrea
    Roma, Roma, Italy
    Not yet recruiting
  • S.C. Radioterapia Oncologica ASL Taranto
    Taranto, Taranto, Italy
    Not yet recruiting
  • Radioterapia Oncologica - Ospedale Sanata Chiara
    Trento, Trento, Italy
    Not yet recruiting
  • S.C. Radioterapia Oncologica - Azienda Ospedaliera Santa Maria Terni
    Terni, Tr, Italy
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.