RecruitingPhase 3NCT04079049

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

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


Sponsor

Umeå University

Enrollment

200 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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

Exclusion Criteria4

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

Interventions

PROCEDURESurgical intervention

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

DRUGControl

Oncological treatment in control group


Locations(1)

Umeå University Hospital

Umeå, Sweden

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NCT04079049


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