NCT04079049 BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
| NCT ID | NCT04079049 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Umeå University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2020-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Oskar Hemmingsson, MD, PhD
PRINCIPAL INVESTIGATOR
Umeå University
Frequently Asked Questions
Who can join the NCT04079049 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04079049 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT04079049 currently recruiting?
Yes, NCT04079049 is actively recruiting participants. Contact the research team at oskar.hemmingsson@umu.se for enrollment information.
Where is the NCT04079049 trial being conducted?
This trial is being conducted at Umeå, Sweden.
Who is sponsoring the NCT04079049 clinical trial?
NCT04079049 is sponsored by Umeå University. The principal investigator is Oskar Hemmingsson, MD, PhD at Umeå University. The trial plans to enroll 200 participants.
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