BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases

Breast cancer is the second most common cancer in Sweden with an incidence of 8000 per year. The role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver. The purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. The primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. The secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. The aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. The overall purpose is to ameliorate treatment for advanced breast cancer.

NCT Number	NCT04079049
Lead Sponsor	Umeå University Collaborators: Uppsala University, Karolinska Institutet, Linkoeping University, Lund University, Göteborg University
Conditions	Breast Cancer, Liver Metastases
Enrollment	200 participants
Start Date	2020-01-01
Primary Completion	2029-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2022-05-25