BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
Recruiting now · Phase 3
Conditions studied: Breast Cancer, Liver Metastases
In brief
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.
Key facts
- Study ID
- NCT04079049
- Run by
- Umeå University
- People needed
- 200
- Starts
- 2020-01-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2022-05-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Non-skeletal extrahepatic disease
- Non-resected primary tumour
- Pregnancy
- Progression of disease upon oncological treatment
Where it is running
- Umeå University Hospital — Umeå, Sweden (enrolling)
Full record on ClinicalTrials.gov
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