Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study

Study Overview
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Brief Summary
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The liver represents the third most common site of breast cancer (BC) metastases behind the lymphatics and bone. The primary treatment for BCLM remains chemo-therapy and, more recently, targeted immunotherapy. The role of liver resection in BCLM remains controversial. The primary aim of the study is to compare the efficacy of liver resection vs. medical therapy alone in Breast Cancer Liver Metastasis (BCLM) patients.

Detailed Description
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In this multicenter observational ambispective study, will be enrolled all patients with BCLM underwent liver resection or medical treatment alone afferent to the Fondazione Policlinico Gemelli IRCSS of Rome (Italy), and other 8 International centers The study foresees two distinct phases: I phase (only retrospective phase): it will cover all patients underwent to either medical treatment or surgery for which all data are available, with a follow up of 5 years at March 31, 2023. All patients data will be recovered from January 1994 till March 31, 2018. At the end of phase I, is provided an ad interim analysis. II phase (ambispective): All patients retrieved from the archives between April 1, 2018 and the April 30, 2023 will be included, as well as all prospectively enrolled patients till December 31 2023, so that the last patient enrolled will end the 5-years follow-up phase within December 31, 2028. The primary endpoint is to analyze the efficacy of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone. The secondary endpoints are: recurrence rate; post-operative mortality (in patients who underwent to surgical treatment), post-operative complication (in patients who underwent to surgical treatment). And also: to assess potential predictive factors of 5-years overall survival in patients with breast cancer who underwent to either liver resection or medical therapy alone, to assess recurrence free survival (RFS) of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone and to assess potential predictive factors of 5-years RFS in patients with breast cancer who underwent to either liver resection or medical therapy alone.

Official Title
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Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study

Conditions
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Breast Cancer, Liver Metastases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years old BCLM BCLM and extra-hepatic disease Any treatment Ability to understand and sign the informed consent Exclusion Criteria: Inability to provide the informed consent Patient who underwent Best Supportive Care or Palliation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BCLM-surg<br>BCLM underwent liver resection | |
| BCLM-med<br>BCLM underwent medical treatment alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-years overall survival | The efficacy of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer | 2018-2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, liver metastasis, liver surgery