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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03758976
• Other study ID #: SCAN-B-rec
• Status: Recruiting
• Start date: January 21, 2019
• Est. completion date: December 1, 2030

Study information

• Verified date: August 2021
• Source: Lund University Hospital
• Contact: Karolina Holm, PhD
• Phone: +46 730 84 17 61
• Email: karolina.holm[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.	10 years