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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå) |
| Status | Recruiting |
| Started | January 1, 2020 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | May 25, 2022 |
| Trial ID | NCT04079049 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
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Umeå University Hospital
Umeå, Sweden Recruiting
Study contacts
- Principal investigator: Oskar Hemmingsson, MD, PhD — Umeå University
- Study coordinator: Oskar Hemmingsson, MD, PhD
- Email: oskar.hemmingsson@umu.se
- Phone: 0046707197548
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.