Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Local treatment for breast cancer that has spread to the liver

Official title: Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases

Run by Umeå University · NCT04079049 · Data updated 2026-11-12

This study is testing whether surgery for liver cancer that has spread from breast cancer can help patients live longer and feel better compared to regular treatments.

More Breast Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorUmeå University
Academic / other
Locations1 site (Umeå)
StatusRecruiting
StartedJanuary 1, 2020
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedMay 25, 2022
Trial IDNCT04079049 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with a history of breast cancer and 1-4 liver metastases that are amenable to surgical intervention.

Probably not a fit

Patients with non-skeletal extrahepatic disease or those whose primary tumor has not been resected 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 clinical trial evaluates the effectiveness of local surgical treatment for liver metastases in breast cancer patients compared to standard systemic oncological treatment. It is a multicenter randomized trial that aims to determine the impact of surgery on overall survival and quality of life. The primary endpoint is the time to death from any cause, while secondary endpoints include three-year survival rates, progression-free survival, and overall safety. The study seeks to improve treatment outcomes for patients with advanced breast cancer.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with breast cancer liver metastases.

How similar studies have gone: Previous studies have suggested potential survival benefits from surgical resection of oligometastases, indicating that this approach may have been successful in similar contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Signed informed consent
* \>18 years old
* ECOG 0-1
* Breast cancer history
* Breast cancer liver metastasis verified by biopsy
* Patient amendable for liver surgery and pre- and postoperative oncological treatment
* 1-4 liver metastasis amendable to surgery with functional liver remnant volume \>30%
* Liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment

Exclusion Criteria:

* Non-skeletal extrahepatic disease
* Non-resected primary tumour
* Pregnancy
* Progression of disease upon oncological treatment

Where it's running

  • Umeå University Hospital
    Umeå, Sweden
    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.