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

Who is this study for? Patients with Breast Cancer, Liver Metastases
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Umeå University Hospital
RECRUITING
Umeå
Contact Information
Primary
Oskar Hemmingsson, MD, PhD
oskar.hemmingsson@umu.se
0046707197548
Backup
Malin Sund, MD, PhD
malin.sund@umu.se
0046907850000
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Surgical intervention
Surgical and oncological treatment
Active_comparator: Control
Oncological treatment
Related Therapeutic Areas
Sponsors
Collaborators: Linkoeping University, Karolinska Institutet, Uppsala University, Göteborg University, Lund University
Leads: Umeå University

This content was sourced from clinicaltrials.gov