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Recruiting NCT03758976

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

Observational Metastatic Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsies, blood.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer

Overview

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.

Interventions

  • Diagnostic test Biopsies, blood
    We will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer

Primary outcome measures

  • Survival [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 2 centers
  • Lund University Hospital — Lund
  • Lund University Hospital — Lund

Identifiers

NCT: NCT03758976 · SCAN-B-rec

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗