Clinical trial: NCT06093022
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: R**Isks Arising From Participation In The Study**

Participation in the study does not involve any investigation or treatment other than that provided for in normal clinical practice and therefore there will be no additional risk in the study compared to clinical practice.  
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Clinical trial: NCT06093022
Section: Procedures
Subsections: What Your Participation In The Study Entails

The study plans to do additional investigations on data recovered from the medical archives of each participating center for all patients enrolled retrospectively. Prospective enrolled patient data will instead be collected in the relevant medical records and reported, together with all other patient data, in an electronic dataset protected by password and accessible only to the IP and coinvestigators, and any other person authorized by PI. The study will overall last 68 months and foresees two distinct phases. The first phase (retrospective phase only) will cover all patients underwent medical or surgical treatment for which all data are available, with a follow-up of 5 years at March 31, 2023. The second phase (ambispective) will also include all patients recovered from archives between 1 April 2018 and 30 April 2023, as well as all patients prospectively enrolled until 31 December 2023, ending the 5-year follow-up by 31 December 2028. 720 patients will participate in this research, including 35 at this hospital.
Clinical trial: NCT06093022
Section: Purpose of Research
Subsections: W**Hat The Study Proposes**|W**Hat Benefits You May Receive From Participating In The Study**

Primary aim of the study is to compare the efficacy of liver resection vs. medical therapy alone in Breast Cancer Liver Metastasis (BCLM) patients. With this research, we intend to obtain data on the overall 5-year survival in patients with breast cancer undergoing liver resection or medical therapy alone.

Participation in this study is not directly beneficial to you, but your participation will allow us to acquire additional information about the disease that you are suffering from.
Clinical trial: NCT06093022
Section: Withdrawal from Study
Subsections: W**Hat Happens If You Decide Not To Participate In The Study**

You are free not to participate in the study. In this case, however, you will receive all the standard therapies provided for your pathology, without any penalty, and the doctors will continue to follow you with due care.