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

Umeå University

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer; Liver Metastases

Treatments: Drug: Control; Procedure: Surgical intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04079049

BreCLIM-2018-116-31M

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Surgical intervention

Experimental group

Description:

Surgical and oncological treatment

Treatment:

Procedure: Surgical intervention

Control

Active Comparator group

Description:

Oncological treatment

Treatment:

Drug: Control