Actively Recruiting
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
Led by Umeå University · Updated on 2022-05-25
200
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
U
Uppsala University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age over 18 years
- ECOG performance status 0-1
- History of breast cancer
- Breast cancer liver metastasis confirmed by biopsy
- Candidate for liver surgery and pre- and postoperative cancer treatment
- 1 to 4 liver metastases suitable for surgery with functional liver volume over 30%
- Liver and bone metastases stable or responding to preoperative cancer treatment
You will not qualify if you...
- Presence of cancer outside the liver and bones
- Primary breast tumor not removed
- Pregnancy
- Disease progression during cancer treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Umeå University Hospital
Umeå, Sweden, 90185
Actively Recruiting
Research Team
O
Oskar Hemmingsson, MD, PhD
CONTACT
M
Malin Sund, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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