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NCT Number: NCT07397585

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Perrino, Brindisi, BR, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. progression free survival

    Time frame: from January 2010 to December 2023

    years of survival without disease progression assessed by imaging

Secondary outcomes

  1. Local Control

    Time frame: from January 2010 to December 2023

    time between treatment and disease recurrence assessed by imaging

  2. overall survival

    Time frame: From January 2010 to December 2023

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

  3. acute and late toxicity RT related

    Time frame: from January 2010 to December 2023

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Bonavita, Master Degree

CONTACT

[email protected]

+39 0282247026

Ruggero Spoto, MD, Radiation oncologist

CONTACT

[email protected]

+39 0282248508

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: ORIETTA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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