RecruitingPhase 3NCT04079049

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


Sponsor

Umeå University

Enrollment

200 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This randomized controlled trial is testing whether surgically removing breast cancer that has spread to the liver (liver metastases), combined with standard cancer treatment, leads to better outcomes than standard cancer treatment alone. This approach is being studied in selected patients with limited liver spread. **You may be eligible if...** - You have a history of breast cancer - You have 1 to 4 liver metastases (cancer spots in the liver) confirmed by biopsy - Your liver metastases are stable or responding to your current cancer treatment - You are suitable for liver surgery and have more than 30% healthy liver tissue remaining after surgery - Your performance status is good (ECOG 0–1) - Bone metastases (if present) are stable or responding to treatment **You may NOT be eligible if...** - You have cancer spread to organs other than the liver and bones - Your primary breast cancer tumor has not been removed - You are pregnant - Your disease is progressing (getting worse) despite cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical intervention

Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment

DRUGControl

Oncological treatment in control group


Locations(1)

Umeå University Hospital

Umeå, Sweden

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NCT04079049


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