Stereotactic body radiotherapy for extracranial oligometastatic breast cancer
stereOtactic Body RadIothErapy for exTracranial oligomeTastAtic Breast Cancer: Multi Institutional Retrospective Database
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 28 sites (Benevento, Benevento and 27 other locations) |
| Trial ID | NCT07397585 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Benevento, Benevento and 27 other locations
- Aorn San Pio — Benevento, Benevento, Italy (Not_yet_recruiting)
- Humanitas Gavazzeni — Bergamo, Bergamo, Italy (Recruiting)
- Ospedale Perrino — Brindisi, Br, Italy (Not_yet_recruiting)
- Spedali Civili — Brescia, Bs, Italy (Recruiting)
- Responsible Research Hospital — Campobasso, Cb, Italy (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)
- Fondazione I.R.C.C.S Istituto Nazionale Tumori di Milano — Milan, Milano, Italy (Recruiting)
- Ieo — Milan, Milano, Italy (Not_yet_recruiting)
- IRCCS Humanitas Research Humanitas — Rozzano, Milano, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Milan, Italy (Not_yet_recruiting)
- INT IRCCS Fondazione G. Pascale — Naples, Napoli, Italy (Recruiting)
- Ospedale Maggiore della Carita — Novara, Novara, Italy (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)
- Irccs Crob — Rionero in Vulture, Pz, Italy (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 Policlinico Universitario, Campus-Biomedico — Roma, Roma, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.