Actively Recruiting
Breast Cancer Liver Metastases-2 A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
Led by Umeå University · Updated on 2022-05-25
200
Participants Needed
1
Research Sites
N/A
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 a common cancer with a significant number of cases involving liver metastases, which are cancer spread to the liver. This trial is designed to compare the effects of adding local surgical treatment for liver metastases to standard systemic cancer treatment for patients with advanced breast cancer, aiming to improve survival and quality of life. Researchers will also study the safety of these treatments and factors that might predict patient outcomes during both surgical and oncological care. The trial includes two groups: one receiving surgery to remove or treat liver metastases through methods like liver resection, ablation, or stereotactic body radiotherapy alongside standard cancer treatment, and a control group receiving only systemic oncological treatment. Surgery candidates must have 1 to 4 liver metastases suitable for removal and stable or improving disease after initial cancer therapy. Treatment and follow-up are planned across multiple centers. Participants will be monitored for survival over three years after randomization, with evaluations of overall survival, progression-free survival, and quality of life. The study will track safety throughout treatment and collect information on how well patients respond to therapies. Total participation time covers years following the initial treatment to assess long-term outcomes.
CONDITIONS
Brief 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 cancer treatment before and after surgery
- 1 to 4 liver metastases suitable for surgery with functional liver volume over 30%
- Stable or responding liver and skeletal metastases to preoperative cancer treatment
You will not qualify if you...
- Presence of non-skeletal extrahepatic disease
- Unremoved primary breast tumor
- Pregnancy
- Disease progression during cancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of treatment as per protocol
Participants receive either surgical intervention including liver resection, ablation, or stereotactic body radiotherapy in addition to oncological treatment, or oncological treatment alone, depending on their assigned group.
Trial Site Locations
Total: 1 location
1
Umeå University Hospital
Umeå, Sweden, 90185
Actively Recruiting
Research Team
O
Oskar Hemmingsson, MD, PhD
M
Malin Sund, MD, PhD
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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