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

Breast Cancer Clinical Trial

— BreCLIM-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04079049
• Other study ID #: BreCLIM-2018-116-31M
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2020
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2022
• Source: Umeå University
• Contact: Oskar Hemmingsson, MD, PhD
• Phone: 0046707197548
• Email: oskar.hemmingsson[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå

Sponsors (6)

Lead Sponsor	Collaborator
Umeå University	Göteborg University, Karolinska Institutet, Linkoeping University, Lund University, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Time to death from any cause	Three years after randomization