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

NCT03758976 | Recruiting

• 1 other identifier: SCAN-B-rec
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; Molecular profiling; Circulating tumor DNA; Circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• Survival

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

  10 years

Interventions

Biopsies, blood DIAGNOSTIC_TEST

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

Also known as: Targeted exon sequencing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with metastatic, inoperable breast cancer.

You may qualify if:

• 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).
• Signed informed consent according to ICH/GCP, and national/local regulations.

You may not qualify if:

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

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (2)

Lund University Hospital

Lund, 221 85, Sweden

RECRUITING

Lund University Hospital

Lund, 221 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopsy, whole blood.

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

Biopsy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Punctures

Central Study Contacts

Karolina Holm, PhD

CONTACT

+46 730 84 17 61; karolina.holm@med.lu.se

Christel Reutersward, MSc

CONTACT

christel.reutersward@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 29, 2018
• Study Start: January 21, 2019
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-03

Locations

SE (2)