Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 32 for:    breast cancer liver metastases
Previous Study | Return to List | Next Study

BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases (BreCLIM-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079049
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : May 25, 2022
Sponsor:
Collaborators:
Uppsala University
Karolinska Institutet
Linkoeping University
Lund University
Göteborg University
Information provided by (Responsible Party):
Umeå University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Liver Metastases Procedure: Surgical intervention Drug: Control Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Surgical intervention
Surgical and oncological treatment
 Procedure: Surgical intervention
Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment
Active Comparator: Control
Oncological treatment
 Drug: Control
Oncological treatment in control group


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Survival [ Time Frame: Three years after randomization ]
    Time to death from any cause


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079049


Contacts
Layout table for location contacts
Contact: Oskar Hemmingsson, MD, PhD 0046707197548 oskar.hemmingsson@umu.se
Contact: Malin Sund, MD, PhD 0046907850000 malin.sund@umu.se

Locations
Layout table for location information
Sweden
Umeå University Hospital Recruiting
Umeå, Sweden, 90185
Contact: Oskar Hemmingsson, MD, PhD    0046 707197548    oskar.hemmingsson@umu.se   
Contact: Anne Andersson, MD, PhD    0046 907850000    anne.andersson@umu.se   
Sponsors and Collaborators
Umeå University
Uppsala University
Karolinska Institutet
Linkoeping University
Lund University
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Oskar Hemmingsson, MD, PhD Umeå University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT04079049    
Other Study ID Numbers: BreCLIM-2018-116-31M
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Digestive System Neoplasms
Liver Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Diseases