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Clinical Trials in Italy / NCT07397585
Recruiting Observational

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

NCT07397585 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Clinico Humanitas
Phase
Observational
Started
2025-02-25
Last updated
2026-02-11

Condition(s) studied

Breast CancerOligometastasis

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • progression free survival — from January 2010 to December 2023
    years of survival without disease progression assessed by imaging

Trial sites (28)

FacilityCityRegionStatus
Aorn San Pio Benevento Benevento Not Yet Recruiting
Humanitas Gavazzeni Bergamo Bergamo Recruiting
Ospedale Perrino Brindisi BR Not Yet Recruiting
Spedali Civili Brescia BS Recruiting
Responsible Research Hospital Campobasso CB Recruiting
Azienda Ospedaliera Universitaria Careggi Florence Firenze Not Yet Recruiting
Irccs Ospedale Policlinico San Martino Genova Genova Not Yet Recruiting
A.O.U. "G. Martino" - Università degli Studi di Messina Messina Messina Not Yet Recruiting
Fondazione I.R.C.C.S Istituto Nazionale Tumori di Milano Milan MILANO Recruiting
IEO Milan Milano Not Yet Recruiting
IRCCS Humanitas Research Humanitas Rozzano MILANO Recruiting
IRCCS Ospedale San Raffaele Milan Milan Not Yet Recruiting
INT IRCCS Fondazione G. Pascale Naples Napoli Recruiting
Ospedale Maggiore della Carita Novara NOVARA Recruiting
Civico Palermo Palermo Palermo Not Yet Recruiting
Istituto Oncologico Veneto Padova PD Not Yet Recruiting
Azienda Ospedaliera Universitaria Pisana Pisa PI Not Yet Recruiting
IRCCS Centro di Riferimento Oncologico di Aviano Aviano Pordenone Not Yet Recruiting
Uo Radioterapia Aor San Carlo Potenza PZ Not Yet Recruiting
Irccs Crob Rionero in Vulture PZ Recruiting
UOC Radioterapia Ospedale San Filippo Neri Roma RM Not Yet Recruiting
Azienda Ospedaliera San Giovanni Addolorata Roma RM Not Yet Recruiting
Fondazione Policlinico Universitario, Campus-Biomedico Roma Roma Recruiting
Fondazione PTV Policlinico Tor Vergata Roma Roma Not Yet Recruiting
Azienda Ospedaliera Sant'Andrea Roma Roma Not Yet Recruiting
S.C. Radioterapia Oncologica ASL Taranto Taranto Taranto Not Yet Recruiting
Radioterapia Oncologica - Ospedale Sanata Chiara Trento TRENTO Not Yet Recruiting
S.C. Radioterapia Oncologica - Azienda Ospedaliera Santa Maria Terni Terni TR Not Yet Recruiting

More Istituto Clinico Humanitas trials in Italy

Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg (PATTERN) Active, not recruiting
Critical Illness Weakness Outside the Intensive Care Unit. Recruiting
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes. Recruiting
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA Recruiting
AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART) Active, not recruiting

Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07397585 on ClinicalTrials.gov ↗ ← All trials in Italy