Breast CancerPhase 3BreCLIM-2NCT04079049
BreCLIM-2 - A RCT Investigating Local Treatment for Breast Cancer Liver Metastases
A Phase 3 study testing Surgical intervention in people with Breast Cancer and Liver Metastases, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Liver Metastases
- What is being tested?
- Surgical intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-skeletal extrahepatic disease
- Non-resected primary tumour
- Pregnancy
- Progression of disease upon oncological treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Umeå University Hospital
Umeå, 90185
Oskar Hemmingsson, MD, PhD, 0046 707197548, oskar.hemmingsson@umu.se
Anne Andersson, MD, PhD, 0046 907850000, anne.andersson@umu.se
About this study
Official title: Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
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
- Breast Cancer, Liver Metastases
- Being tested
- Surgical intervention, Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical interventionProcedure or surgery
Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment
ControlDrug
Oncological treatment in control group
| Study group | Role | What they receive |
|---|---|---|
| Surgical intervention | Experimental | Surgical and oncological treatment Receives: Procedure: Surgical intervention |
| Control | Active comparator | Oncological treatment Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Time to death from any cause
Measured: Three years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Karolinska Institutet, Linkoeping University, Lund University, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Oskar Hemmingsson, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079049
- Sponsor's protocol ID
- BreCLIM-2018-116-31M
- Acronym
- BreCLIM-2
- Status last verified
- May 2022
- First submitted
- 2 Sep 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT04079049
- Acronym / sponsor ID
- BreCLIM-2 / BreCLIM-2018-116-31M
- Conditions
- Breast Cancer, Liver Metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Uppsala University, Karolinska Institutet, Linkoeping University, Lund University, Göteborg University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention | Experimental | Procedure: Surgical interventionSurgical and oncological treatment |
| Control | Active comparator | Drug: ControlOncological treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- >18 years old
- ECOG 0-1
- Breast cancer history
- Breast cancer liver metastasis verified by biopsy
Key exclusion criteria (4 listed)
- Non-skeletal extrahepatic disease
- Non-resected primary tumour
- Pregnancy
- Progression of disease upon oncological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical interventionSurgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment | Procedure or surgery | Surgical intervention |
| ControlOncological treatment in control group | Drug | Control |
Primary outcome
Survival
Time frame: Three years after randomization
Time to death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oskar Hemmingsson, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgical intervention in people with Breast Cancer and Liver Metastases, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oskar Hemmingsson, MD, PhD (0046707197548, oskar.hemmingsson@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Three years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.