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Recruiting NCT06093022

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

— Observational Breast Cancer Liver Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer, Liver Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 5-years overall survival [Time frame: 2018-2023]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Publications

  • Diamond JR, Finlayson CA, Borges VF. Hepatic complications of breast cancer. Lancet Oncol. 2009 Jun;10(6):615-21. doi: 10.1016/S1470-2045(09)70029-4. PMID 19482250
  • Arciero CA, Guo Y, Jiang R, Behera M, O'Regan R, Peng L, Li X. ER+/HER2+ Breast Cancer Has Different Metastatic Patterns and Better Survival Than ER-/HER2+ Breast Cancer. Clin Breast Cancer. 2019 Aug;19(4):236-245. doi: 10.1016/j.clbc.2019.02.001. Epub 2019 Feb 14. PMID 30846407
  • Ma R, Feng Y, Lin S, Chen J, Lin H, Liang X, Zheng H, Cai X. Mechanisms involved in breast cancer liver metastasis. J Transl Med. 2015 Feb 15;13:64. doi: 10.1186/s12967-015-0425-0. PMID 25885919
  • DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2. PMID 31577379
  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. PMID 33433946
  • Howlader M, Heaton N, Rela M. Resection of liver metastases from breast cancer: towards a management guideline. Int J Surg. 2011;9(4):285-91. doi: 10.1016/j.ijsu.2011.01.009. Epub 2011 Jan 31. PMID 21281746
  • Golse N, Adam R. Liver Metastases From Breast Cancer: What Role for Surgery? Indications and Results. Clin Breast Cancer. 2017 Jul;17(4):256-265. doi: 10.1016/j.clbc.2016.12.012. Epub 2017 Jan 9. PMID 28196771
  • Rashid NS, Grible JM, Clevenger CV, Harrell JC. Breast cancer liver metastasis: current and future treatment approaches. Clin Exp Metastasis. 2021 Jun;38(3):263-277. doi: 10.1007/s10585-021-10080-4. Epub 2021 Mar 6. PMID 33675501

Identifiers

NCT: NCT06093022 · 5795

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗