BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
NCT04079049
Summary
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.
Eligibility
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
Conditions5
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT04079049