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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 28 sites (Benevento, Benevento and 27 other locations) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07397585 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
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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
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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
- Study coordinator: Ruggero Spoto, MD, Radiation oncologist
- Email: ruggero.spoto@cancercenter.humanitas.it
- Phone: +39 0282248508
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.