Local Treatment for Breast Cancer Liver Metastases
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
Recruiting
Phase 3Interventional Study
Breast CancerLiver Metastases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Umeå University · Other
Who this trial is looking for
This trial is looking for people with breast cancer that has spread to the liver. Participants will receive either local treatment combined with regular cancer treatment or just the regular treatment alone.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have signed the informed consent
I have a history of breast cancer
I have liver metastasis confirmed by a biopsy
I can undergo liver surgery
I have 1-4 liver metastases that can be surgically removed
My liver metastasis is stable or responding to treatment
You may not be able to join if
I have cancer that has spread outside the liver
I have not had my primary tumor removed
I am pregnant
My cancer has worsened during treatment
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 treatmen…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 li…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.