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

Primary Purpose

Breast Cancer, Liver Metastases

Status
Recruiting
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Surgical intervention
Control
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Umeå University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgical intervention

Control

Arm Description

Surgical and oncological treatment

Oncological treatment

Outcomes

Primary Outcome Measures

Survival
Time to death from any cause

Secondary Outcome Measures

Full Information

First Posted
September 2, 2019
Last Updated
May 24, 2022
Sponsor
Umeå University
Collaborators
Uppsala University, Karolinska Institutet, Linkoeping University, Lund University, Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04079049
Brief Title
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
Acronym
BreCLIM-2
Official Title
Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Uppsala University, Karolinska Institutet, Linkoeping University, Lund University, Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Liver Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical intervention
Arm Type
Experimental
Arm Description
Surgical and oncological treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Oncological treatment
Intervention Type
Procedure
Intervention Name(s)
Surgical intervention
Intervention Description
Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Oncological treatment in control group
Primary Outcome Measure Information:
Title
Survival
Description
Time to death from any cause
Time Frame
Three years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oskar Hemmingsson, MD, PhD
Phone
0046707197548
Email
oskar.hemmingsson@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Malin Sund, MD, PhD
Phone
0046907850000
Email
malin.sund@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oskar Hemmingsson, MD, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umeå University Hospital
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oskar Hemmingsson, MD, PhD
Phone
0046 707197548
Email
oskar.hemmingsson@umu.se
First Name & Middle Initial & Last Name & Degree
Anne Andersson, MD, PhD
Phone
0046 907850000
Email
anne.andersson@umu.se

12. IPD Sharing Statement

Learn more about this trial

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

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