Local treatment for breast cancer that has spread to the liver
Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
PHASE3 · Umeå University · NCT04079049
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University (other) |
| Locations | 1 site (Umeå) |
| Trial ID | NCT04079049 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with non-skeletal extrahepatic disease or those whose primary tumor has not been resected may not benefit from this study.
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 performed: Previous studies have suggested potential survival benefits from surgical resection of oligometastases, indicating that this approach may have been successful in similar contexts.
Eligibility criteria
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 this trial is running
Umeå
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Liver Metastases