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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patient with Oligometastatic or oligoprogressive metastatic breast cancer treated with SBRT

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: TREATMENT SBRT

Trial outcomes

Primary outcomes

1

progression free survival

years of survival without disease progression assessed by imaging

Time frame
from January 2010 to December 2023

Secondary outcomes

1

Local Control

time between treatment and disease recurrence assessed by imaging

Time frame
from January 2010 to December 2023
2

overall survival

the time from diagnosis or initiation of treatment until death from any cause

Time frame
From January 2010 to December 2023
3

acute and late toxicity RT related

Evaluation of toxicities related to radiotherapy treatment using the scale CTCAE (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)

Time frame
from January 2010 to December 2023

Other outcomes

Sponsors and contacts

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