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

NCT04079049 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-05-25

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Surgical intervention

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

DRUG

Control

Oncological treatment in control group

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Lund University

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Umeå University

    lead OTHER

Principal Investigators

  • Oskar Hemmingsson, MD, PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079049 on ClinicalTrials.gov