NCT04079049

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

Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Liver Metastases

Interventions

Type	Name	Description
PROCEDURE	Surgical intervention	Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment
DRUG	Control	Oncological treatment in control group

Timeline

• Start date: 2020-01-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2019-09-06
• Last updated: 2022-05-25

Locations

1 site across 1 country: Sweden