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Trial Title:
Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study
NCT ID:
NCT06093022
Condition:
Breast Cancer
Liver Metastases
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
breast cancer
liver metastasis
liver surgery
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
All patient with BCLM underwent liver resection or medical treatment alone.
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Amelia Mattia, MD
Phone:
+390453015
Phone ext:
4868
Email:
amelia.mattia01@icatt.it
Start date:
April 1, 2018
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06093022
