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

May 24, 2022 updated by: Umeå University

Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: Three years after randomization
Time to death from any cause
Three years after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Karolinska Institutet
Lund University
Uppsala University
Göteborg University
Linkoeping University

Investigators

  • Principal Investigator: Oskar Hemmingsson, MD, PhD, Umea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2029

Study Completion (Anticipated)

December 31, 2029

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BreCLIM-2018-116-31M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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