Spots Global Cancer Trial Database for BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
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Trial Identification
Brief Title: BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
Official Title: Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
Study ID: NCT04079049
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Umeå University Hospital, Umeå, , Sweden
Contact Details
Name: Oskar Hemmingsson, MD, PhD
Affiliation: Umeå University
Role: PRINCIPAL_INVESTIGATOR
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