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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. Identifier: NCT04079049
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : May 25, 2022
Uppsala University
Karolinska Institutet
Linkoeping University
Lund University
Göteborg University
Information provided by (Responsible Party):
Umeå University

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

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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

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

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

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT04079049

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Contact: Oskar Hemmingsson, MD, PhD 0046707197548
Contact: Malin Sund, MD, PhD 0046907850000

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Umeå University Hospital Recruiting
Umeå, Sweden, 90185
Contact: Oskar Hemmingsson, MD, PhD    0046 707197548   
Contact: Anne Andersson, MD, PhD    0046 907850000   
Sponsors and Collaborators
Umeå University
Uppsala University
Karolinska Institutet
Linkoeping University
Lund University
Göteborg University
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Principal Investigator: Oskar Hemmingsson, MD, PhD Umeå University
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Responsible Party: Umeå University 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

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