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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

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

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.

Inclusion criteria

  1. Patients with pathologically confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease.
  2. Age > 18 years.
  3. Performance status according to Eastern Cooperative Oncology Group (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 informed consent 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.

04

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

05

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

06

Study locations

2 of 2 sites recruiting
  • Lund University Hospital
    Lund, 221 85, Sweden
    • Karolina Holm, PhD · Contact · karolina.holm@med.lu.se · +46 730 84 47 61
    • Ana Bosch Campos, MD, PhD · Contact · ana.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
    Recruiting
  • Lund University Hospital
    Lund, 221 85, Sweden
    • Karolina Holm, MSc · Contact · karolina.holm@med.lu.se · +46 730 84 47 61
    • Åke Borg, Professor · Principal investigator
    Recruiting
07

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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