Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Liver Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Drug | — | UNRESOLVED |
| Surgical intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgical intervention
- description
- Surgical and oncological treatment
- interventionNames
- Procedure: Surgical intervention
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Oncological treatment
- interventionNames
- Drug: Control
Primary outcomes (1)
- measure
- Survival
- timeFrame
- Three years after randomization
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available