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

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

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

Conditions5

Interventions1

Related trials

• A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients — Suzhou Immunofoco Biotechnology Co., Ltd
• Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease — Gruppo Oncologico del Nord-Ovest
• Probiotic Supplements in Osteoarthritis — Beni-Suef University
• SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer — First Affiliated Hospital of Zhejiang University
• The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium — Beth Israel Deaconess Medical Center

Browse More Trials