Clinical trial Recruiting at 1 site Observational Ages 18 and up

Comparing surgery and medical treatment for breast cancer that has spread to the liver

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

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06093022 · Data updated 2026-11-12

This study is testing whether surgery or just medical treatment works better for people with breast cancer that has spread to the liver.

More Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment720 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Drugs / interventionsimmunotherapy
Locations1 site (Rome, Lazio)
StatusRecruiting
StartedApril 1, 2018
Main results expectedOctober 31, 2024
Study endsDecember 31, 2028
Registry record updatedNovember 14, 2023
Trial IDNCT06093022 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old diagnosed with breast cancer liver metastasis.

Probably not a fit

Patients who are receiving best supportive care or palliative treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to compare the effectiveness of liver resection versus medical therapy alone in patients with breast cancer liver metastasis (BCLM). It consists of two phases: a retrospective analysis of patients treated from 1994 to 2018 and an ambispective phase including patients treated from 2018 to 2023. The primary endpoint is to evaluate the 5-year overall survival rates between the two treatment approaches, while secondary endpoints include recurrence rates and post-operative complications. Data will be collected from multiple international centers, focusing on a comprehensive analysis of treatment outcomes.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment options for patients with breast cancer liver metastasis, potentially improving survival rates.

How similar studies have gone: While the role of liver resection in BCLM is controversial, similar studies have explored surgical interventions in metastatic cancers, indicating potential for significant findings.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Rome, Lazio, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.