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RecruitingNCT03758976Updated Sep 16, 2025

Sweden Cancerome Analysis Network - Breast Recurrence (SCAN-B-rec)

An observational study in Metastatic Breast Cancer, sponsored by Lund University Hospital. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Lund University Hospital · Observational

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Metastatic Breast Cancer

Keywords

  • Metastatic breast cancer
  • Molecular profiling
  • Circulating tumor DNA
  • Circulating tumor cells
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Lund University Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with metastatic, inoperable breast cancer.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease.
  2. Age > 18 years.
  3. Performance status according to (ECOG) ≤ 2.
  4. 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).
  5. Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion.
  6. Signed according to ICH/GCP, and national/local regulations.

Exclusion criteria

Exclusion Criteria:

Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testBiopsies, blood

    We will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer

    Also known as: Targeted exon sequencing

06

What researchers measure

Primary outcomes

  1. Survival

    Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.

    Time frame: 10 years

07

Study locations

2 of 2 sites recruiting
  • Lund University Hospital
    Lund, 221 85, Sweden
    Recruiting
    • Karolina Holm, PhD · Contactkarolina.holm@med.lu.se · +46 730 84 47 61
    • Ana Bosch Campos, MD, PhD · Contactana.bosch_campos@med.lu.se · +46 46 17 76 03
    • Åke Borg, Professor · Principal investigator
    • Ana Bosch Campos, MD, PhD · Sub investigator
    • Anna-Maria Larsson, MD, PhD · Sub investigator
    • Lao Saal, Associated professor · Sub investigator
    • Johan Staaf, Associated professor · Sub investigator
  • Lund University Hospital
    Lund, 221 85, Sweden
    Recruiting
    • Karolina Holm, MSc · Contactkarolina.holm@med.lu.se · +46 730 84 47 61
    • Åke Borg, Professor · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03758976
Lead sponsor
Lund University Hospital
Responsible party
Sponsor
First posted
Nov 29, 2018
Start date
Jan 21, 2019
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 1, 2030 (estimated)
Last update
Sep 16, 2025

Study contacts

Karolina Holm, PhD
Contact
karolina.holm@med.lu.se
+46 730 84 17 61
Christel Reutersward, MSc
Contact
christel.reutersward@med.lu.se

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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