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

Phase 3

Recruiting

• Conditions: Liver Metastases; Breast Cancer
• Interventions: Procedure: Surgical intervention; Drug: Control

• Registration Number: NCT04079049
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Study Start: 2020-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical intervention	Surgical intervention	Surgical and oncological treatment
Control	Control	Oncological treatment

Primary Outcome Measures

Name	Time	Method
Survival	Three years after randomization	Time to death from any cause

Trial Locations

Locations (1)

Umeå University Hospital; 🇸🇪 Umeå, Sweden