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

NCT04079049 | Recruiting Phase 3 DMC

• 1 other identifier: BreCLIM-2018-116-31M
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Survival

  Time to death from any cause

  Three years after randomization

Study Arms (2)

Surgical intervention

EXPERIMENTAL

Surgical and oncological treatment

Procedure: Surgical intervention

Control

ACTIVE COMPARATOR

Oncological treatment

Drug: Control

Interventions

Surgical intervention PROCEDURE

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

Surgical intervention

Control DRUG

Oncological treatment in control group

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• liver metastasis amendable to surgery with functional liver remnant volume \>30%
• Liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment

You may not qualify if:

• Non-skeletal extrahepatic disease
• Non-resected primary tumour
• Pregnancy
• Progression of disease upon oncological treatment

Sponsors & Collaborators

• Umeå University: lead
• Uppsala University: collaborator
• Karolinska Institutet: collaborator
• Linkoeping University: collaborator
• Lund University: collaborator
• Göteborg University: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, 90185, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oskar Hemmingsson, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oskar Hemmingsson, MD, PhD

CONTACT

0046707197548; oskar.hemmingsson@umu.se

Malin Sund, MD, PhD

CONTACT

0046907850000; malin.sund@umu.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

SE (1)