| Registry | NCT07397585, acronym ORIETTA |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 300 (Estimated) |
| Sponsor | Istituto Clinico Humanitas (Other) |
| Conditions | Breast Cancer, Oligometastasis |
| Dates | start 2025-02-25, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-02-09, last updated 2026-02-11 |
| Locations | 28 sites in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer All trials for Oligometastasis
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TREATMENT SBRT | patients who have been treated with stereotactic radiotherapy to oligometastatic sites |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |