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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT06093022
Collaborator
(none)
720
Enrollment
1
Location
129
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this multicenter observational ambispective study, we will enroll 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. We will retrieve all patients data from January 1994 till March 31, 2018. At the end of "phase I", we foresee an "ad interim" analysis.

    • II phase (ambispective): we will further include all patients retrieved from the archives between April 1, 2018 and the April 30, 2023, 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    720 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study
    Actual Study Start Date :
    Apr 1, 2018
    Anticipated Primary Completion Date :
    Oct 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    BCLM-surg

    BCLM underwent liver resection
    BCLM-med

    BCLM underwent medical treatment alone

    Outcome Measures

    Primary Outcome Measures

    1. 5-years overall survival [2018-2023]

      The efficacy of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT06093022
    Other Study ID Numbers:
    • 5795
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    breast cancer
    liver metastasis
    liver surgery
    Additional relevant MeSH terms:
    Breast Neoplasms
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Oct 23, 2023