Metastatic Breast CancerNCT03758976
Sweden Cancerome Analysis Network - Breast Recurrence (SCAN-B-rec)
An observational study of Metastatic Breast Cancer, run by Lund University Hospital at 2 sites in Sweden.
Trial summary
Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure. The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Biopsies, blood
- How many people
- 2,000 participants
- Where
- 2 sitesSweden
- Study dates
- 21 Jan 2019to 1 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
Study population: Patients diagnosed with metastatic, inoperable breast cancer.
Who may be able to join
- Patients with pathologically confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease.
- Age > 18 years.
- Performance status according to Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- ABC must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT-scan), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET).
- Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion.
- Signed informed consent according to ICH/GCP, and national/local regulations.
Who cannot join
- Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christel Reutersward, MSc contact
Sweden2 sites, 2 recruiting
- Recruiting
Lund University Hospital
Lund, 221 85
Karolina Holm, PhD, +46 730 84 47 61, karolina.holm@med.lu.se
Ana Bosch Campos, MD, PhD, +46 46 17 76 03, ana.bosch_campos@med.lu.se
- Recruiting
Lund University Hospital
Lund, 221 85
Karolina Holm, MSc, +46 730 84 47 61, karolina.holm@med.lu.se
Åke Borg, Professor
About this study
Official title: SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer
Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure.
The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.These data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Biopsies, blood
- Keywords
- Metastatic breast cancer, Molecular profiling, Circulating tumor DNA, Circulating tumor cells
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies, bloodDiagnostic test
Also called Targeted exon sequencing
We will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start21 Jan 2019
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758976
- Sponsor's protocol ID
- SCAN-B-rec
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2018
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03758976
- Acronym / sponsor ID
- SCAN-B-rec
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, Molecular profiling, Circulating tumor DNA, Circulating tumor cells
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 29 Nov 2018 (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.
Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure.
The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.These data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with metastatic, inoperable breast cancer.
Key inclusion criteria (6 listed)
- Patients with pathologically confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease.
- Age > 18 years.
- Performance status according to Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- ABC must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT-scan), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET).
- Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion.
Key exclusion criteria (1 listed)
- Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.
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 |
|---|---|---|
| Biopsies, bloodAlso: Targeted exon sequencingWe will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer | Diagnostic test | – |
Primary outcome
Survival
Time frame: 10 years
Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.
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 16 Sep 2025.
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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.
Christel Reutersward, MSc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Lund University Hospital at 2 sites 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 6 inclusion and 1 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Karolina Holm, PhD (+46 730 84 17 61, karolina.holm@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 10 years). 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 16 Sep 2025.