BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical intervention, Control.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Liver Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
Overview
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.
Interventions
- 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
Primary outcome measures
- Survival [Time frame: Three years after randomization]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Non-skeletal extrahepatic disease
- Non-resected primary tumour
- Pregnancy
- Progression of disease upon oncological treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Umeå University Hospital — Umeå
Identifiers
NCT: NCT04079049 · BreCLIM-2018-116-31M