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NCT Number: NCT04079049

BreCLIM-2 - A RCT 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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Liver Metastases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical intervention

Procedure

Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment

Control

Drug

Oncological treatment in control group

Primary outcomes

  1. Survival

    Time frame: Three years after randomization

    Time to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Malin Sund, MD, PhD

CONTACT

[email protected]

0046907850000

Oskar Hemmingsson, MD, PhD

CONTACT

[email protected]

0046707197548

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Göteborg University
  • Karolinska Institutet
  • Linkoeping University
  • Lund University
  • Uppsala University

Registry information

Official study title

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

Acronym: BreCLIM-2

Important dates

Study start
2020
Primary completion
2029
Study completion
2029
First posted
Sep 6, 2019
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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